MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Material Integrity Problem (2978); Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Therapy date: (b)(6) 2022.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00208.

Event Description

It was reported that there was a revision due to implant fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.It was reported that the patient was implanted with a revitan stem on (b)(6) 2017 and underwent revision surgery due to stem fracture on (b)(6) 2022.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.However, since other involved devices such as head, liner and shell are unknown, the compatibility of other involved devices could not be verified.Review of complaint history identified no similar complaints for the reported item/lot combinations.Complaints are monitored through monthly complaint review (reference (b)(4) monthly complaint trending) in order to identify potential adverse trends.Medical records were not provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was reported that the patient was implanted with a revitan stem and underwent revision surgery due to stem fracture.No product was returned or images provided as the devices are examined by an external institution.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.One pre-revision ap radiograph of the pelvis was provided showing a pin fracture of the distal stem at the stem junction, which is located at the level of the lesser trochanter.The proximal stem is in a medially tilted position.The surgical report states in the indication that the patient suddenly experienced pain in the right hip joint after implantation of a total hip prosthesis following a misstep, after being symptom-free for several years.Further, in the description of the technical procedure it is noted that there is a stem fracture in the area of the stem junction.The proximal part is loose and not osseointegrated.The distal part of the stem is firmly fixed in the bone.The patient was implanted with the shortest proximal stem part size 55; leading to a proximal location of the stem junction at the level of the lesser trochanter, which can be seen on the provided pre-revision radiograph.This proximal position of the stem junction increases the bending force on the taper and the risk for stem fracture.Further, based on the radiograph and the surgical report, the proximal stem was found to be loose, while the distal stem was found to be firmly fixed in the femur.Therefore, it is possible that loosening of the proximal stem in combination with the firmly fixed distal stem and the proximal location of the stem junction due to the short proximal part led or contributed to the pin fracture.However, since no x-ray follow-up was provided it remains unknown at what point in time the loosening occurred.In addition, contributing patient factors such as bmi, type and level of physical activity, and medical history of the patient remain unknown.In conclusion, based on the investigation a pin fracture of the distal revitan stem can be confirmed.Nevertheless, due to the unavailability of the devices, and since the cause may be multifactorial, consisting of device-, patient- and procedure-related factors, a definitive root cause could not be identified.

Event Description

It was reported that after misstep patient hip implant has been revised due to implant fracture and loosening.

Event Description

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

Manufacturer Narrative

(b)(4).D10: item#:01.00406.120 ;lot#:2877767 ; item name: revitan distal part curved uncemented 20/140; g2-foreign-switzerland.This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, d10, g2, g3, g6, h3, h6, h10.The fractured revitan stem with mounted biolox head was received for examination.The distal and proximal components of the revitan stem show damages from the revision surgery in the form of scratches and nicks.No bone ongrowth can be seen on the anchoring surface of the proximal component.On the medial side, the proximal component has a fine polish, which most likely derived from micromotions against bone.Only little bone attachments can be found on the anchoring surface of the distal component.There is a drill hole in the distal component that was likely used to remove the stem during the revision procedure.The connection pin of the distal component is fractured in the not blasted area.The fracture surfaces point to a fatigue fracture with the origin located on the lateral side.The biolox delta head looks inconspicuous with some slight metallic smearing deriving most likely from the removal.The durasul insert has scratches and dents as well as a drill hole from the revision surgery.Review of the device history records identified no deviations or anomalies during manufacturing.One pre-revision ap radiograph of the pelvis was provided showing a pin fracture of the distal component at the stem junction, which is located approximately at the level of the lesser trochanter.The proximal component is in a medially tilted position.The surgical report states in the indication that the patient suddenly experienced pain in the right hip joint after implantation of a total hip prosthesis following a misstep, after being symptom-free for several years.Further, in the description of the technical procedure it is noted that there is a stem fracture in the area of the stem junction.The proximal component is loose and not osseointegrated.The distal component of the stem is firmly fixed in the bone.The patient was implanted with the shortest proximal component, leading to a proximal location of the modular connection which was located approximately at the level of the lesser trochanter as seen on the provided pre-revision radiograph.Based on the literature, this proximal position of the modular connection increases the mechanical stresses on the taper and thus increases the risk for stem fracture by fatigue.Further, based on the radiograph and the surgical report, the proximal component was found to be loose.This loosening is also confirmed by the absence of any bone ongrowth on this component and the polished areas seen on the medial side, which most likely derived due to micromotions against bone.The distal component was found to be firmly fixed in the femur.Therefore, it is possible that loosening of the proximal component in combination with the firmly fixed distal component as well as the proximal location of the modular connection led or contributed to the pin fracture by fatigue.However, since no x-ray follow-up was provided it remains unknown at what point in time the loosening of the proximal component occurred.In addition, contributing patient factors such as bmi, type and level of physical activity, and medical history of the patient remain unknown.In conclusion, based on the investigation a pin fracture by fatigue of the distal revitan component can be confirmed.Nevertheless, 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14
• 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: 13946672
• MDR Text Key: 288169305
• Report Number: 0009613350-2022-00207
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024503007
• UDI-Public: (01)00889024503007(17)220228(10)2894510
• 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
• Report Date: 09/28/2022

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00402.055
• Device Lot Number: 2894510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 06/14/2022; 06/30/2022; 09/27/2022
• Supplement Dates FDA Received: 06/20/2022; 07/26/2022; 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR