MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N ZIMMER MMC CUP

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01. 00185. 145; lot#: 2565568. Metasul ldh, head, 48, code n, taper 18/20; catalog#: 01. 00181. 480; lot#: 2551767. Femoral stem beaded fullcoat 12/14 neck taper std. Body std. Offset size 11 11 mm distal dia. 160 mm length; catalog #: 00-7843-011-06; lot#: 61710257. Therapy date: (b)(6) 2020. The manufacturer received other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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).

Event Description

Patient underwent an initial right hip resurfacing which was converted into a right tha due to femoral neck fracture. The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery. During the second revision surgery a large metallosis fluid collection in the deep subcutaneous tissue, pseudotumor, moderate trunionosis around the base of the trunnion and significant metallosis within the acetabulum and cavitary osteolytic defects were reported.

• Brand Name: ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N
• Type of Device: ZIMMER MMC CUP
• 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: 11957648
• MDR Text Key: 255054907
• Report Number: 0009613350-2021-00267
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.00634.056
• Device Lot Number: 2564524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2010
• 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 Treatment Data

Date Received: 06/08/2021 Patient Sequence Number: 1