MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140; HIP PROTESIS

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that ten years after implantation, the patient had to undergo a revision surgery due to loosening of the cone of the modular stem and massive metallosis.Stem and cup were revised.There was a 300 minutes surgical delay reported because of the metallosis.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products:- medical device: revitan, proximal part, cylindrical, uncemented, 65, taper 12/14; item# 0100402065; lot# 2627400.Report source- foreign: (b)(6).According to a costumer the product won't be returned.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00298.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

Additional information received states: after a minor trauma, the patient felt increasing discomfort in the left hip area.Radiologically, a fracture between the distal and proximal parts of the shaft is suspected.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a4, b5, b7, d10, g6, h2.D10 - medical devices: cocr head 28/0 m taper/12/14; item# 14280620; lot# 2640900.Original m.E.Muller ring; item# 56975649; lot# 2627104.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the image provided shows that the revitan stem is disconnected at the connection between the connection pin and the distal stem body.The proximal component and the connection pin are still assembled.No bone ongrowth can be seen on the visible surfaces of the proximal component.Some bone ongrowth appears to be present on the visible surfaces of the distal component.Polished areas that appear silvery on the image can be seen on the proximal and distal components.On the proximal component the metal head and the liner are still assembled.The liner shown is not a zimmer biomet product.No product was returned; therefore, a detailed device examination could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.The surgical reports provided were reviewed and are summarized as follows.Review revealed a revision stage 2 total hip arthroplasty performed after the patient was cleared from infection.During the procedure, a competitor¿s dual mobility cup with a revitan stem was placed.Following a minor trauma, the patient was revised due to disassociation of the proximal and distal stem components.During the revision procedure, it was noted that the connection pin had detached from the distal component.Abundant play developed between the connection pin and the distal component with titanium wear.Correspondingly abundant metallotically altered tissue was resected.Further, metallosis as well as a partial loosening of the acetabular ring was noted.All components were revised and replaced with competitor products.Based on the investigation a dissociation of the connection pin and the distal part can be confirmed.However, due to the lack of a complete radiographic follow-up, laboratory results and the unavailability of the devices, a detailed investigation could not be performed.Therefore, the reported metallosis as well as its cause cannot be confirmed.Based on the literature, factors such as patient age, weight and activity level, comorbidities, location of the stem junction, insufficient medial bone support to the proximal part, as well as patient trauma may have led or contributed to the dissociation of the connection pin and the distal part.Since the cause may be multifactorial, consisting of device-, patient- and procedure-related factors, a single definitive root cause could not be identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(6).This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g3, g6, h2, h3, h6, h10 visual examination of the image provided shows that the revitan stem is disconnected at the connection between the connection pin and the distal stem body.The proximal component and the connection pin are still assembled.No bone ongrowth can be seen on the visible surfaces of the proximal component.Some bone ongrowth appears to be present on the visible surfaces of the distal component.Polished areas that appear silvery on the image can be seen on the proximal and distal components.On the proximal component the metal head and the liner are still assembled.The liner shown is not a zimmer biomet product.The revitan stem with mounted cocr head and mounted polarcup insert was received together with 3 screws and one piece of bone cement.For examination of the zimmer biomet devices, the polarcup insert was removed from the cocr head.The polarcup insert is not a zimmer biomet device and was therefore not examined.The revitan stem was received disconnected at the connection between the connection pin and the distal stem body.The proximal stem and the connection pin are still assembled.Apart from countless fine scratches on the articulation surface, the cocr head appears inconspicuous.Revision damage in the form of scratches and nicks can be seen on the proximal stem, especially on the lateral side and the stem neck.Further, spot-like marks possibly from an electrocautery tool can be found on the stem neck.There are no signs of bone ongrowth on the anchoring surface of the proximal stem.The press-fit region of the connection pin is not anymore in its original condition and shows a mixture of polishing, smearing and fretting.Revision damage in the form of scratches can be found on all sides of the distal stem.Additional revision damage is present on the lateral side in the form of a drill hole and a straight cut, most likely from a saw blade, running perpendicular to the stem axis and through the four lateral flanks.Bone ongrowth can be seen on the anchoring surface of all four sides of the distal stem.The distal face surface of the proximal stem is highly worn and polished, especially on the medial flank.The medial wall of the distal stem is worn at the inside to the extent that the wall thickness is significantly diminished.Further, especially the inside of the lateral wall is highly worn and polished.From the three screws, one is fractured at the first thread below the screw head.The other two screws and the piece of bone cement appear inconspicuous.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.The surgical reports provided (implantation report and revision report) were reviewed and are summarized as follows.Review revealed a revision stage 2 total hip arthroplasty performed in 2012 after the patient was cleared from infection.During the procedure, a competitor¿s dual mobility cup with a revitan stem was placed.Following a minor trauma, the patient was revised due to disassociation of the proximal and distal stem components.During the revision procedure, it was noted that the connection pin had detached from the distal component.Abundant play developed between the connection pin and the distal component with titanium wear.Correspondingly abundant altered tissue was resected.Further, metallosis as well as a partial loosening of the acetabular ring was noted.All components were revised and replaced with competitor products.Two ap pelvis views were provided.The stem junction of the revitan stem is located approximately at the level of the lesser trochanter and there seems to be insufficient medial bone support to the proximal part.There is a fractured acetabular fixation screw on the image of 2015.Further, compared to the image from 2012, a sclerotic seam along the lateral side of the proximal component can be seen on the image from 2015.Based on the investigation a dissociation of the connection pin from the distal part can be confirmed.However, due to the lack of a complete radiographic follow-up, and laboratory results (e.G.Attesting metallosis), a detailed investigation could not be performed.If and to what extend the metal wear seen on the revised component may have contributed to the reported metallosis cannot be evaluated.Therefore, the reported metallosis as well as its cause cannot be confirmed.Based on the literature, factors such as patient age, weight and activity level, comorbidities (e.G.Previous infection), location of the stem junction, insufficient medial bone support to the proximal part (e.G.Indicated by the sclerotic seam in the radiograph of 2015), as well as patient trauma (e.G.As mentioned in the surgical note) may have led or contributed to the dissociation of the connection pin and the distal part.Since the cause may be multifactorial, consisting of patient- and procedure-related factors, a single definitive root cause could not be identified.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10- cancellous bone screw, countersunk, 㸠6.5x20, item# 421920, lot# 4503968582; cancellous bone screw, countersunk, 㸠6.5x35, item# 421935, lot# 10.582492 (intact); cancellous bone screw, countersunk, 㸠6.5x35, item# 421935, lot# 10.582492 (fractured); investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140
• Type of Device: HIP PROTESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14494260
• MDR Text Key: 292572178
• Report Number: 0009613350-2022-00297
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024593015
• UDI-Public: (01)00889024593015(17)160430(10)2605625
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.118
• Device Lot Number: 2605625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/31/2022; 09/06/2022; 10/21/2022; 12/20/2022; 03/17/2023
• Supplement Dates FDA Received: 06/08/2022; 09/30/2022; 11/04/2022; 01/17/2023; 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG