MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: unknown wagner cone stem.Establishment name: (b)(6).Source: foreign country: japan.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01711 and 0001825034-2022-01712.

Event Description

A journal article was retrieved from journal of orthopaedics (2022) that reported a retrospective study from japan that looked at stem options for altered morphology of the proximal femur in patients with previous femoral osteotomy.The purpose of the study was to assess the short-term results of total hip arthroplasty (tha) after femoral osteotomy using a tapered cone stem, and to identify issues that require further attention.The study reviewed 21 patients who underwent tha after femoral osteotomy.The primary diagnosis was osteonecrosis in nine hips, developmental dysplasia of the hip in eight hips, and benign chondroblastoma within the femoral head in one hip that had been treated with femoral osteotomy after excision of the tumor.The diagnosis of the remaining three hips that had been treated during infancy was unknown.Tha was performed through the posterolateral approach.A wagner cone stem was used in the femurs.Cementless acetabular cups were used in all procedures, including the g7 cup in 15 hips and the continuum cup in 6 hips (zimmer biomet).The head size was 32 mm in 20 hips and 28 mm in one hip.Crosslinked polyethylene was used in all hips, consisting of an elevated liner in 11 hips and a neutral liner in 10 hips.The study population had a mean age of 59.6 years at time of surgery (range 40-77 years); 5 males, 16 females.Follow-up was conducted clinically and radiographically with a mean length of follow-up for 34.4 months (range 24-50 months).The study reported one patient developed a superficial infection that was treated by wound irrigation.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.The following sections were updated/corrected updated: h2; h3; h6 no product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

No further event information available at the time of this report.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920 ponce.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920 ponce.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15098744
• MDR Text Key: 296556576
• Report Number: 0001825034-2022-01713
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model 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: 09/12/2022
• 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