MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC 133 T1 PPS SO 11X142MM T1; PROSTHESIS, HIP

Catalog Number 51-103110

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: tprlc 133 t1 pps ho 13x146mm 6mm t1 cat# 51-104130 lot# 3711469, tprlc 133 t1 pps ho 11x142mm 2mm t1 cat# 51-104110 lot# 3765796, tprlc 133 t1 pps ho 16x152mm 2mm t1 cat# 51-104160 lot# 3458649, tprlc 133 t1 pps ho 16x152mm 2mm t1 cat# 51-104160 lot# 2469061, tprlc 133 t1 pps ho 11x142mm 2mm t1 cat# 51-104110 lot# 3677485.(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: 0001825034-2020-01535, 0001825034-2020-01536, 0001825034-2020-01537, 0001825034-2020-01538, 0001825034-2020-01540.

Event Description

It was reported that debris was identified within sterile packaging.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 complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned packages showed white debris within the sterile packaging.The inserts were damaged such that particles had become detached to float freely within the sterile packaging.The debris was consistent with the foam packaging inside the sterile barrier.The blister seal remained intact and the outer package appeared roughened through handling with no noticeable damage.The device history records were reviewed and no discrepancies were identified.The likely condition of the product when it left zimmer biomet was conforming to specification.Therefore, the root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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: TAPERLOC 133 T1 PPS SO 11X142MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9938854
• MDR Text Key: 188860811
• Report Number: 0001825034-2020-01539
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• 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: 07/01/2020

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: 51-103110
• Device Lot Number: 3455274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1