MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GG POROUS UNCEMENTED WITH MULTI-HOLES SHELL USE WITH GG LINERS; PROSTHESIS, HIP

Catalog Number	00875704802
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report souce: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00199, 0002648920-2022-00200, 0002648920-2022-00201, 0002648920-2022-00202.Journal article: https://doi.Org/10.1016/j.Jor.2022.02.021.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch 3500a will be submitted.
Event or Problem 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 approximately 1 (one) month after surgery.No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: during the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.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.

• Brand Name: GG POROUS UNCEMENTED WITH MULTI-HOLES SHELL USE WITH GG LINERS
• Common Device Name: PROSTHESIS, HIP
• 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: 15494096
• Report Number: 0001822565-2022-02780
• Device Sequence Number: 13920745
• Product Code: LPH
• UDI-Device Identifier: 00889024151321
• UDI-Public: (01)00889024151321(17)260831(10)63440364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 00875704802
• Device Lot Number: 63440364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WAGNER CONE STEM GENERIC
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 49 KG