MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 12X144MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported that during an initial hip arthroplasty, the pps coating deboned from the stem.Some debris was not removed from the patient as it was not easily removable.Additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Source: (b)(6).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 further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified a spec of black debris as reported in the wound.Reported event was confirmed by review of photographs provided.A review of the device history records identified no related deviations or anomalies during manufacturing.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.

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.H6: component code: mechanical (g04) - stem.A tprlc 133 t1 pps so 12x144mm was returned and evaluated against the complaint.Visual inspection found metallic debris on the returned cloth and inside the poly bag that is visually consistent with the porous coating material.The porous coating appears to be thin near the collar and elbow.Blood stains and foreign debris are present on the coating and distal end of the stem.Complaint sample was evaluated and the reported event was confirmed.The additional information does not change the outcome to the previous investigation.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 12X144MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12869917
• MDR Text Key: 281215349
• Report Number: 0001825034-2021-03194
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304491823
• UDI-Public: (01)00880304491823(17)301125(10)6899276
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-103120
• Device Lot Number: 6899276
• 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: 11/04/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 01/28/2022; 05/05/2022
• Supplement Dates FDA Received: 02/02/2022; 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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 Outcome(s): Other