MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC 133 T1 PPS SO 14X148MM T1; PROSTHESIS, HIP

Catalog Number 51-103140

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Concomitant medical products: tprlc 133 t1 pps so 16x152mm t1, cat# 51-103160, lot# 3886526.Tprlc xr mp t1 pps 13x111mm 111mm t1, cat# 51-145130, lot# 3894668.Tprlc 133 mp type1 pps so 17.0 1, cat# 51-106170, lot# 6037496.Report source: (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: 0001825034-2020-00170, 0001825034-2020-00171, 0001825034-2020-00172.

Event Description

It was reported debris was identified within the sterile packaging.There was no patient involvement as this was discovered at the distributor's office.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.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.The reported event is confirmed and sterility of the product is intact.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.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: TAPERLOC 133 T1 PPS SO 14X148MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9574257
• MDR Text Key: 205024544
• Report Number: 0001825034-2020-00169
• Device Sequence Number: 1
• Product Code: MAY
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-103140
• Device Lot Number: 3892150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1