MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 15X115MM 115MM T1; PROSTHESIS, HIP

Catalog Number 51-145150

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products : tprlc 133 t1 pps ho 13x146mm 6mm, t1 cat#51-104130 lot# 3799301, tprlc xr mp t1 pps 14x113mm 113mm, t1 cat# 51-145140 lot# 3150390, tprlc xr mp t1 pps 16x117mm 117mm, t1 cat# 51-145160 lot# 2920949, tprlc xr mp fp t1 pps 5x95mm t1, cat#51-149050 lot#3446162, tprlc xr mp t1 pps 16x117mm 117mm, t1 cat#51-145160 lot#3011809.Foreign country: (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: 0001825034-2020-00886, 0001825034-2020-00888, 0001825034-2020-00889, 0001825034-2020-00890, 0001825034-2020-00891.

Event Description

It was reported that debris was found within sterile packages.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.The following sections were updated: b4, b5, d4, d10, g4, g7, h2, h3, h4, h6, h10 visual evaluation of the returned products identified that there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.The complaint has been confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 to become abraded and shed.The event is being addressed through the capa process.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 is available at the time of this report.

• Brand Name: TPRLC XR MP T1 PPS 15X115MM 115MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9763335
• MDR Text Key: 201044714
• Report Number: 0001825034-2020-00887
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-145150
• Device Lot Number: 3577454
• 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: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1