MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC XR FP TYPE1 PPS 5X130MM 1; PROSTHESIS, HIP

Catalog Number 51-102050

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: tprlc 133 fp type1 pps ho 5.0 t1 cat# 51-101050 lot# 3692721, tprlc 133 fp type1 pps ho 5.0 t1 cat# 51-101050 lot# 3590153, tprlc 133 t1 pps ho 17x154mm 4mm t1 cat# 51-104170 lot# 3706660, tprlc xr t1 pps 17x154mm mm t1 cat# 51-105170 lot# 3096162, tprlc 133 fp type1 pps ho 5.0 t1 cat# 51-101050 lot# 2588486.(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: 0001825034-2020-01378, 0001825034-2020-01379, 0001825034-2020-01380, 0001825034-2020-01382, 0001825034-2020-01383.

Event Description

It was reported that debris was identified within sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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.

Event Description

No further event information available at the time of this report.

• Brand Name: TAPERLOC XR FP TYPE1 PPS 5X130MM 1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9900135
• MDR Text Key: 185903840
• Report Number: 0001825034-2020-01381
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2024
• Device Catalogue Number: 51-102050
• Device Lot Number: 3368426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1