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

Catalog Number 51-145170

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.Concomitant medical devices: item# 51-105170/ tprlc xr t1 pps/ lot # 3011823; item # 51-105160/ tprlc xr t1 pps /lot # 6133648; item# 51-107140/ tprlc 133 mp type1 pps/ lot# 6359748; item# 51-107170/ tprlc 133 mp type1 pps/ lot# 3743544; item# 51-145140/ tprlc xr mp t1 pps / lot# 6314883; item# 51-100040/ tprlc 133 fp type1 pps / lot# 6051655.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports 0001825034 -2021 -00358, 0001825034 -2021 -00359, 0001825034 -2021 -00360, 0001825034 -2021 -00361, 0001825034 -2021 -00362, 0001825034 -2021 -00363.

Event Description

It was reported that the while reviewing product at the distributorship, it was noted the product was found to have debris inside the sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d9; g3; h2; h3; h4; h6 visual evaluation of the returned product/photographs provided confirmed there is white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.The reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to transit damage causing the foam packaging and porous coating to become abraded and shed.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Further, there was no adverse event as a result of the reported event.Therefore, event is no longer considered reportable, and initial report should be voided.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.

• Brand Name: TPRLC XR MP T1 PPS
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11280707
• MDR Text Key: 230323950
• Report Number: 0001825034-2021-00357
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K1200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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 Catalogue Number: 51-145170
• Device Lot Number: 6411825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1