MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 16/140; HIP PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported that patient underwent revision due to pain.During the procedure, the femoral shaft was found to be loose with a large amount of black debris in the joint.All components were replaced without complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source: foreign-germany.Concomitant associated products: item number: 01.00401.055, lot number: 2402536, item name: revitan, proximal part, cylindrical, uncemented, 55, taper 12/14.Item number: unknown, lot: unknown, item name: unknown sulox head 28.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00120.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information d10: associated products: item number: 17.28.07, lot: unknown, item name: sulox⿢, head, l, 㸠28/+3.5, taper 12/14.The revitan stem was returned for examination with a sulox head mounted on the stem taper.The revitan stem was received disconnected at the connection between the connection pin and the distal part; the proximal part and the connection pin were still assembled.The sulox head shows some metallic smearing on the articulating surface.Revision damages in the form of scratches, nicks and polished areas can be seen on the proximal part, especially on the lateral side.There are no signs of bone ongrowth on the anchoring surfaces of the proximal part.Revision damage in the form of scratches can be found on all outer sides of the distal part.Additionally, there is revision damage on the anterior side in the form of a drill hole.Bone ongrowth can be seen on the anchoring surfaces on all sides of the distal part.The press-fit region of the connection pin is not anymore in its original condition and shows scratches, polished areas, and fretting corrosion.The face surfaces of the distal and the proximal parts are partially polished and worn.Further, the anterolateral wall in the distal drill hole shows signs of wear most likely deriving from contact with the loosened pin.Four pictures of the device were provided and assessed.However, as these do not provide any additional information that is not already included in the device examination, no further documentation is provided here.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.A total of four x-rays were provided and reviewed by a radiologist.Two undated radiographs taken before revision surgery were provided: an ap pelvis overview and a single view of the right hip.The radiographs show a right total hip arthroplasty with undersized femoral head.There is osteopenia and radiolucency in the region of the right greater trochanter which could indicate underlying osteolysis.Further, there is a slight offset of the femoral neck and stem junction, which could indicate loosening.The other two undated radiographs which were taken after the second revision surgery were assessed but are not documented, as they do not provide any additional information.A total of five intraoperative photographs, allegedly taken during second revision surgery, were received.Three images show the surgical site and the distal stem after removal of the proximal part.Blackened tissue can be seen adjacent to the remaining distal stem.The other two images also show the surgical site with the distal stem in place, which has a drill hole to which a surgical instrument is attached to.In conclusion, based on the investigation a dissociation of the connection pin of the revitan stem from the distal part is confirmed.Nevertheless, since the cause may be multifactorial, consisting of device-, patient- and procedure-related factors, a 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.

• Brand Name: REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 16/140
• Type of Device: HIP PROSTHESIS
• 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: 16590005
• MDR Text Key: 311752245
• Report Number: 0009613350-2023-00119
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024592995
• UDI-Public: (01)00889024592995(17)120531(10)2389854
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.116
• Device Lot Number: 2389854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: 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; SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 85 KG