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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during a right hip procedure, the implant would not seat.Surgery was completed with another implant.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
This follow-up report is being submitted to relay additional information.A taperloc stem was returned.Visual evaluation identified the following: the porous coating was intact and there was no visible damage.Dimensional analysis confirmed the dimensions were conforming to print specifications, where measured.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Visual evaluation of the device found no damage.Dimensional analysis confirmed the length was conforming to print specifications, and the collar width was measured during manufacturing and found to be conforming.Therefore, there is no problem with the device and it operated within specifications.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 T1 PPS SO 10X140MM T1
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11516937
• Report Number: 0001825034-2021-00808
• Device Sequence Number: 3625117
• Product Code: KWA
• UDI-Device Identifier: 00880304489684
• UDI-Public: 00880304489684
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 51-103100
• Device Lot Number: 6384903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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
• Patient Weight: 71