MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 14X113MM; PROSTHESIS, HIP

Catalog Number 51-145140

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: tprlc 133 t1 pps ho 16x152mm: cat# 51-104160, lot# 6047712.Tprlc 133 t1 pps ho 9x137mm: cat# 51-104090, lot# 6057369.Tprlc xr mp t1 pps 14x113mm: cat# 51-145140, lot# 3545229.Tprlc xr mp t1 pps 17x119mm: cat# 51-145170, lot# 3730608.Tprlc 133 mp type1 pps so 17.0: cat# 51-106170, lot# 3564680.Tprlc 133 mp type1 pps so 17.0: cat# 51-106170, lot# 3669984.Tprlc xr mp t1 pps 16x117mm: cat# 51-145160, lot# 3029799.Report source: foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00679, 0001825034-2020-00680, 0001825034-2020-00681, 0001825034-2020-00683, 0001825034-2020-00684, 0001825034-2020-00685, 0001825034-2020-00686.

Event Description

It was reported that debris was found in sterile packaging while investigating stock.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: b4, b5, d4, d10, g4, h2, h3, h6 complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed there was debris inside the sterile packaging that is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier and black debris consistent with porous material from the device.Device history record (dhr) was reviewed and no discrepancies were found.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage causing the foam packaging and porous material from device to become abraded and shed.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 14X113MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9702146
• MDR Text Key: 206373159
• Report Number: 0001825034-2020-00682
• Device Sequence Number: 1
• Product Code: OQG
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Catalogue Number: 51-145140
• Device Lot Number: 2884150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1