MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SZ 32/53MM HOD INS DURASU; PROTHESIS, HIPS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 00642803203 alumina ceramic femoral head 12/14 taper 32 mm diameter +3.5 mm neck length 60712870.5360-00-053 clstr por shl w/seal 53mm conv 60679965.7356-02-105 ha collarless sz 5 rt nat 1653727.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03766.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was implanted with zimmer biomet products.Subsequently, the patient was revised due to instability and abductor deficiency roughly sixteen years post implantation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right hip arthroplasty.Focus of osteolysis in gruen zone iii of the acetabulum without evidence of implant loosening.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: SZ 32/53MM HOD INS DURASU
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18397322
• MDR Text Key: 331368592
• Report Number: 0001822565-2023-03765
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: 4377-32-053
• Device Lot Number: 1616885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2004
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization