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

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

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 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 Description

No further event information available at the time of this report.

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
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11516937
• MDR Text Key: 240770199
• Report Number: 0001825034-2021-00808
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304489684
• UDI-Public: 00880304489684
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 71