MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 50/44 J; DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices or x-rays for review.Other source documents were provided for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmers reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision due to pain, swelling and elevated metal ions.

Event Description

Patient was implanted on the right side and underwent a revision surgery due to pain, swelling and increased metal ions.Post operative findings were as follows, moderate amount of synovial hypertrophy with loose fibrous tissue surrounding synovium.Discoloration of trunnion.No bony ingrowth on backside.Some grayish loose tissue was observed within the hip joint.Moderate amount of fluid in the hip was observed which was straw colored.Femoral head was removed which showed some evidence of corrosion on trunnion which contained gun metal colored staining.

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, 44, code j, taper 18/20; catalog#: 01.00181.440; lot#: unknown zimmer m/l taper extended offset size #10 femoral stem; catalog#: unknown; lot#: unknown therapy date: (b)(6)2019 additional information received on july 13, 2021.The manufacturer received other source documents (surgical reports)for review.Since this case is related to the issues for which zimmer implemented a notification in (b)(6)2008 as referenced above in h7 and h9, zimmer gmbh will close this case.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: DUROM US ACET CMPNT 50/44 J
• Type of Device: DUROM ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12082707
• MDR Text Key: 258880031
• Report Number: 0009613350-2021-00317
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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 Model Number: N/A
• Device Catalogue Number: 01.00214.150
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613350-07/15/2008-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention