MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 17X154MM; PROSTHESIS HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the incoming inspection observed a black stains on the vinyl bag directly packaging the stem.No adverse events have been reported as a result of the malfunction as there was no patient involvement.

Manufacturer Narrative

Udi#: (b)(4).The reported event has been confirmed through visual inspection of the returned packaging, which confirms black debris is present in the sterile packaging.The black debris appears to be the implant coating transferred from the device to the packaging.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event is likely to be the implant coating has transferred from the implant to the packaging due to friction during the transit process.A corrective action was opened to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this corrective action preventive action the pouch for the device is being improved to use a stronger material (nylon), and foam end caps are being added to prevent friction.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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: TPRLC 133 T1 PPS SO 17X154MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8831375
• MDR Text Key: 196794337
• Report Number: 0001825034-2019-03241
• Device Sequence Number: 1
• Product Code: MEH
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-103170
• Device Lot Number: 6170616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1