MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 7X99MM; PROTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: cat# unk lot# unk unknown size 7 broach.Customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the stem implant was oversized by at least one complete size compared to the broach.The surgeon broached multiple times, with the broach going on very easily but the stem sat about 5 or 6mm proud.The surgeon had to drop from a standard to a -6 neck length, and the stem was implanted.It was determined to likely be an implant issue since there hasn't been an issue with the broach in previous cases.Surgical technique was utilized.There were no patient conditions or anatomy that contributed to the event.There was no patient impact and no surgical delay.No additional information available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and corrected.The following section was corrected: d4.Product will not be returned for analysis.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

• Brand Name: TPRLC 133 MP T1 PPS SO 7X99MM
• Type of Device: PROTHESIS, 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: 18887042
• MDR Text Key: 337455040
• Report Number: 0001825034-2024-00692
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 51-108070
• Device Lot Number: 748515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male