MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN ACETABULAR COMPONENT; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Failure of Implant (1924)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Biolox⮠delta, ceramic femoral head, xl, 㸠40/+7, taper 12/14 item#00877504004 lot#3141169 40mm i.D.Size g high wall liner item#30124007 lot#66152419.To date, the device is not returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00639.

Event Description

It was reported that a total hip arthroplasty was performed in october of this year and the doctor noticed on x-ray postoperatively that the femoral head was not sitting in the center of the acetabular component.A head and poly exchange was surgically performed and it was found that the polyethylene head was not properly locked into the acetabular component.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A review of the device manufacturing records for unknown acetabular component could not be performed due to missing lot number.Device is used for treatment.The reported product was reviewed for compatibility with no issues noted.A review of the complaint history could not be performed for unknown acetabular component due to missing reference and lot numbers.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00639-1.

Event Description

Diligence is complete and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN ACETABULAR COMPONENT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18172459
• MDR Text Key: 328557236
• Report Number: 0009613350-2023-00640
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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 ACETABULAR COMPONENT.
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 137 KG