MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 10X140MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during initial total hip arthroplasty, when the implant was opened it was sticking through the plastic sterile package making it unsterile.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Visual evaluation of the returned product identified that the perforations on the outer carton have been damaged.The complaint has been confirmed by visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing.The product was likely conforming when it left zimmer biomet control.The root cause of the reported issue is attributed to transit damage.This device falls within the scope, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: TPRLC 133 T1 PPS HO 10X140MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10440574
• Report Number: 0001825034-2020-03284
• Device Sequence Number: 2751193
• Product Code: KWL
• UDI-Device Identifier: 00880304491830
• UDI-Public: (01)00880304491830(17)280814(10)6338694
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-104100
• Device Lot Number: 6338694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 08/23/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1