MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 7.0; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product will not be returned to zimmer biomet for the investigation as the product remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a hip procedure, the porous coating peeled off the stem on the proximal lateral shoulder.The stem was able to be implanted as intended with no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TPRLC 133 FP TYPE1 PPS SO 7.0
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12461201
• Report Number: 0001825034-2021-02641
• Device Sequence Number: 13754870
• Product Code: KWA
• UDI-Device Identifier: 00880304489653
• UDI-Public: (01)00880304489653(17)310419(10)6992315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-100070
• Device Lot Number: 6992315
• 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: 08/19/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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
• 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
• Patient Age: 38 YR
• Patient Sex: Female