MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 17X154MM MM T1; PROSTHESIS, HIP

Catalog Number 51-105170

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products : tprlc xr t1 pps 14x148mm mm, t1 cat# 51-105140 lot# 6147982, tprlc 133 mp type1 pps so 14.0 1, cat# 51-106140 lot# 3809821, tprlc xr mp t1 pps 15x115mm 115mm, t1 cat# 51-145150 lot#3017317, tprlc xr mp t1 pps 17x119mm 119mm, t1 cat# 51-145170 lot# 3122354, tprlc 133 mp type1 pps ho 15.0 m t1, cat# 51-107150 lot# 3219017, tprlc 133 mp type1 pps so 16.0 1, cat# 51-106160 lot# 3894715, tprlc 133 mp type1 pps so 17.0 1, cat# 51-106170 lot# 2569136.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: 0001825034-2020-00874, ,0001825034-2020-00875, 0001825034-2020-00876, 0001825034-2020-00877, 0001825034-2020-00878, 0001825034-2020-00879, 0001825034-2020-00880.

Event Description

It was reported that debris was discovered within sterile packages.Attempts have been made and additional information on the reported event is unavailable at this time.

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.The following sections were updated/corrected updated: b4, b5, d4, g4, h2, h3, h6 complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage causing the foam packaging 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.

• Brand Name: TPRLC XR T1 PPS 17X154MM MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9762673
• MDR Text Key: 201030514
• Report Number: 0001825034-2020-00873
• 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: 06/18/2020

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: 51-105170
• Device Lot Number: 3857249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1