MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS SO 9X137MM; PROSTHESIS, HIP

Catalog Number	51-103090
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a hip revision approximately five months¿ post implantation due to aseptic loosening, poor bone quality, and suspected prosthetic joint infection, not clinically confirmed.During the revision noted vasculitis, scar tissue and subsidence of femoral component.The stem, liner, and head were exchanged without complications.The acetabular component remained implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as its location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected component code: mechanical (g04) ¿ stem visual inspection found little significant damage to the returned stem.Watermarks are present on the non-coated, distal end of the stem.Light scuffing was observed around the neck and collar.A small chip or light spot is present in the porous coating.No damage was observed along the spine of the stem.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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: TPRLC 133 TYPE1 PPS SO 9X137MM
• Common Device Name: 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: 15650118
• Report Number: 0001825034-2022-02392
• Device Sequence Number: 2356602
• Product Code: LZO
• UDI-Device Identifier: 00880304498334
• UDI-Public: (01)00880304498334(17)310406(10)6987266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 51-103090
• Device Lot Number: 6987266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/25/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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: UNK HEAD; UNK LINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female