MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 18.0; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a left hip revision approximately 10 months post initial implantation and subsequently had to have a second revision due to pain and loosening of the femoral stem approximately 7 months later.The head and the stem were replaced without complication.There is no additional information provided at the time of this report.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device location is unknown.
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: a3; d4; h2; h3; h4; h6 component code: mechanical (g04) - stem medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised due to pain and difficulty ambulating.Within the joint, the stem was found to be loose with a lack of ingrowth noted.The stem and head were revised with no complications noted.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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 MP TYPE1 PPS SO 18.0
• Common Device Name: PROSTHETIC, 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: 15832947
• Report Number: 0001825034-2022-02633
• Device Sequence Number: 6034902
• Product Code: KWL
• UDI-Device Identifier: 00880304514447
• UDI-Public: (01)00880304514447(17)271219(10)6185849
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-106180
• Device Lot Number: 6185849
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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
• 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
• Patient Sex: Male
• Patient Weight: 114 KG