MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 10X140MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: us257852, magnum trispike cup, 52odx46id, 916000.157446, m2a-magnum mod hd sz 46mm, 787180.139256, m2a-magnum 42-50 tpr insrt std, 445270.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01792, 0001825034 - 2020 - 01794, 0001825034 - 2020 - 02953.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Medical records/radiographs identified the following: pain prior to revision.Osteolysis noted behind acetabular component.500 ml clear joint fluid sent for cultures.Extensive amount of pseudotumor membrane, removed.Osteolytic bone on anterior and posterior aspect of femur.Femoral component, porous ingrowth noted, solidly grown into place.No evidence of wear on head or acetabulum; however pseudomembrane between the ball and femoral component right at the level of the trunnion.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 or Problem Description
It was reported by patients¿ legal counsel that the patient underwent a right hip procedure.The patient was revised seven years later due to pain, metallosis and extensive pseudotumor formation.No additional information is available.

• Brand Name: TPRLC 133 T1 PPS SO 10X140MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10349527
• Report Number: 0001825034-2020-01793
• Device Sequence Number: 2655673
• Product Code: KWA
• UDI-Device Identifier: 00880304489684
• UDI-Public: 00880304489684
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 51-103100
• Device Lot Number: 2624156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention