MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP FP T1 PPS 4X93MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a metal fragment flaked off of the taperloc stem during insertion of implant.No additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of photograph of device fracture.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.No product was returned.A picture of the fractured piece was provided.It appears to be possible part of porous coating.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 XR MP FP T1 PPS 4X93MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10051762
• Report Number: 0001825034-2020-01987
• Device Sequence Number: 2729902
• Product Code: LPH
• UDI-Device Identifier: 00880304517417
• UDI-Public: 00880304517417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 51-149040
• Device Lot Number: 6626643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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