MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR FP TYPE1 PPS 6X132MM 1; 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	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Evaluation of the returned confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.Further evaluation found damage to sterile blister and debris inside the sterile packaging which is consistent with the appearance of the porous coating.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the foreign debris reported event is the operator not following the work instructions provided.The root cause of the white foam and black porous coating debris is likely to be damage during transit.This device falls within the scope of ca-03419 for the black porous coating debris and sterile packaging damage, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this capa, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.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
It was reported that debris was identified in the sterile packaging while investigating items in stock.No patients were involved.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC XR FP TYPE1 PPS 6X132MM 1
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10719052
• Report Number: 0001825034-2020-03868
• Device Sequence Number: 3526509
• Product Code: LPH
• UDI-Device Identifier: 00880304516892
• UDI-Public: (01)00880304516892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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 Expiration Date: 04/23/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-102060
• Device Lot Number: 3773380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/22/2020
• 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: CA-03419
• Patient Sequence Number: 1