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

Catalog Number 51-145160

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Udi# (b)(4).Item# 51-105130/ tprlc xr t1 pps /lot # 2920980, item# 51-104120/ tprlc 133 t1 pps ho / lot #3677492, item# 51-107150/tprlc 133 mp type1 pps lot # 3769795, item# 51-104140/ tprlc 133 t1 pps ho / lot #3387180, item# 51-104160/tprlc 133 t1 pps ho/ lot # 3135988.Source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -02858, 0001825034 -2020 -02859, 0001825034 -2020 -02860, 0001825034 -2020 -02923, 0001825034 -2020 -02924.

Event Description

It was reported that during inspection of product in warehouse, debris was found in 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

This follow-up report is being submitted to relay additional information.Complaint was confirmed by review of provided photographs.Photographs revealed debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event is likely to be due to transit.The event is being further reviewed through the capa process.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 MP T1 PPS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10337458
• MDR Text Key: 200771376
• Report Number: 0001825034-2020-02925
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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 Catalogue Number: 51-145160
• Device Lot Number: 6274221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1