MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L; ZIMMER MMC CUP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Osteolysis (2377)

Event Date 12/17/2021

Event Type  Injury  

Event Description

It was reported that the patient had a revision due to osteolysis.

Manufacturer Narrative

Concomitant medical products: therapy date: date of explantation (b)(6) 2021.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00026 (ref: 01.00634.054 zimmer mmc, cup, uncemented, 54 mm/46 mm, code l) 0009613350-2022-00027 (ref: 01.00181.500 metasul ldh, head, 50, code p, taper 18/20).Neither product nor lot number available.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the patient received an mmc cup and ldh head on (b)(6) 2009, and underwent revision surgery on (b)(6) 2021, because a large area of periacetabular osteolysis was discovered on a radiographic follow-up.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned, as the devices were discarded.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was not approved by zimmer biomet, as the reported mmc cup size 54/46 code l is not compatible with the reported ldh head size 50 code p.Dhr review: review of the device history records could not be performed as the lot numbers are unknown.Conclusion: it was reported that the patient received an mmc cup and ldh head on (b)(6) 2009, and underwent revision surgery on (b)(6) 2021, because a large area of periacetabular osteolysis was discovered on a radiographic follow-up.The investigation did not identify a nonconformance or a complaint out of box (coob).The compatibility check showed, that the reported mmc cup and ldh head are not compatible.Due to the significant lack of medical and product data, the reported event cannot be confirmed.Therefore, no specific cause could be identified.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).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00027-1.

Event Description

Investigation has been completed.

• Brand Name: ZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L
• 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: 13236504
• MDR Text Key: 283676599
• Report Number: 0009613350-2022-00026
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K091003
• 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
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00634.054
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization