MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC XR T1 PPS 13X146MM MM T1; PROSTHESIS, HIP

Catalog Number 51-105130

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: tprlc xr t1 pps 16x152mm mm t1 cat# 51-105160 lot# 3751535.Tprlc xr t1 pps 12x144mm mm t1 cat# 51-105120 lot# 3560787.Tprlc 133 t1 pps so 16x152mm t1 cat# 51-103160 lot# 3581704.Tprlc 133 t1 pps ho 17x154mm 4mm t1 cat# 51-104170 lot# 2457955.Tprlc 133 t1 pps ho 16x152mm 2mm t1 cat# 51-104160 lot# 2548615.(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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01521.0001825034-2020-01522.0001825034-2020-01523.0001825034-2020-01524.0001825034-2020-01525.

Event Description

It was reported debris was identified within sterile packaging.No patients were involved.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.Evaluation of the returned product confirmed the event.Visual inspection confirmed white debris within the sterile packaging.The insert has been damaged such that particles have become detached and float freely within the sterile packaging.The blister seal remains intact.The outer packaging is roughened through handling but no notable damage was observed.Review of the device history records for the reported items identified no deviations or anomalies related to the reported issue during manufacturing.The root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed and/or the porous coating to shed from the implant.A corrective action has been initiated to address the reported event.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.

Event Description

Upon further investigation, it has been determined that the debris is the sterile packaging meets the acceptable criteria specifications.This event is no longer considered reportable.Therefore, the initial report should be voided.

• Brand Name: TAPERLOC XR T1 PPS 13X146MM MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9938119
• MDR Text Key: 187882027
• Report Number: 0001825034-2020-01520
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-105130
• Device Lot Number: 3564650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1