MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/260; HIP PROTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign: germany.Concomitant medical product(s): revitan, proximal part, cylindrical, uncemented, 75, taper 12/14 item#0100402075 lot#2666623.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00066.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent hip revision due to break below cone, approximately nine (9) years nine (9) months from initial operation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

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 corrected information.The following sections were updated: b4, b5, d10, g3, g6, h1, h2, h10.D-10 revitan, proximal part, cylindrical, uncemented, 75, taper (b)(6) item# 0100402075 lot# 2666623 cocr head 32/-4 s 12/14 item# 14320520 lot# 2696578 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

(b)(4).This follow-up report is being submitted to relay corrected information.The following sections were updated: b4, b5, d1, d2, d4, d9, g3, g6, h1, h2, h3, h6, h10.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 information.The revitan stem, and the cocr head were returned for investigation.The distal component of the revitan stem is fractured in two parts and the fracture took place in the area just below the cone.The small fractured part of the distal component is still connected with the proximal component as the press fit with the cone was maintained.The non-articulating surface of the cocr head shows scratches and dents.The articulating surface of the cocr head shows some scratches and milky areas which indicates the wear zone.The distal component shows damages in the form of scratches and nicks most likely from the revision surgery, in particular on the anterior and lateral sides.Bone attachment can be found on the anchoring surfaces of the distal component, but only on the most distal half of the shaft.Around the neck of the proximal component it is possible to see damages in the form of scratches, nicks and polished areas.No bone ongrowth can be seen on the anchoring surface of the proximal component.The small fractured part of the distal component shows an extended polished area on the lateral and posterior side in the proximity of the fracture.This polished area appears also on the long fractured part of the distal component, again in the proximity of the fracture.Comparing the position of the polished areas with the provided x-rays, it is possible to assume that the polished area is due to prolonged contact with the cerclage.The fracture surfaces of the distal component appear quite irregular.However, on the lateral side, it is possible to see beach marks that point to a fatigue fracture.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device used for treatment.Radiographs were provided and reviewed by a radiologist.Acute hardware fracture noted at the level of the proximal cerclage wire with mild medial displacement of the intramedullary stem and mild apex lateral angulation at the fracture site.No confirmed periprosthetic fracture.Cortical undulations and thickening noted throughout the proximal femur possibly indicates the presence of chronic nonunion.Noted a possible incomplete bridging with lucent gap in the proximal femoral diaphysis, distal to the more distal cerclage wire.Nonspecific periprosthetic lucency in the region of the greater trochanter, adjacent to the proximal component, is noted.A possible reason can be attributed to the fracture of the implant itself.Alternatively, if already present before the reported event, the lucency might indicate loosening of the stem and be a contributing factor to the fracture of the stem.Due to lack of images taken at earlier time points, none of these hypotheses can be confirmed.With the available information a definitive root cause cannot be established.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, CURVED, UNCEMENTED, 16/260
• Type of Device: HIP PROTHESIS
• 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: 16406758
• MDR Text Key: 309893371
• Report Number: 0009613350-2023-00067
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024503281
• UDI-Public: (01)00889024503281(17)171130(10)2680744
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/10/2023

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: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 0100406316
• Device Lot Number: 2680744
• 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: 01/27/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 02/04/2023; 03/08/2023; 05/04/2023
• Supplement Dates FDA Received: 03/03/2023; 04/04/2023; 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male