MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM ACETABULAR COMPONENT; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: ldh head hip impl win gen; catalog#: unknown; lot#: unknown.Ldh sleeve hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: (b)(6) 2021.The manufacturer did not receive devices, x-rays, or other source documents 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 above in recall number.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted.The need for further corrective measures is not indicated at this time.(b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to unknown reasons.

Manufacturer Narrative

Additional information which was received on feb 7, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer did not receive any documents for review.Since this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above in h7 and h9, zimmer gmbh will close this case once again zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to unknown reasons.

• Brand Name: DUROM ACETABULAR COMPONENT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11278341
• MDR Text Key: 230234987
• Report Number: 0009613350-2021-00066
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/07/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention