MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 12X109MM; PROSTHESIS, HIP

Catalog Number 51-145120

Device Problem Packaging Problem (3007)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that the packaging was found to be damaged.There was no health consequences or impact to the patient.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3; h4; h6 visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister).Sterility has been compromised.The event is confirmed by the evaluation of the returned products and provided photos.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined.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 T1 PPS 12X109MM
• Type of Device: PROSTHESIS, 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: 18037400
• MDR Text Key: 326907414
• Report Number: 0001825034-2023-02502
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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 Catalogue Number: 51-145120
• Device Lot Number: 3455322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1