MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 12X144MM 4MM T1; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional 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 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d10; g4; h2; h3; h6 evaluation of the returned product/photographs provided confirmed the following: lot #3595240: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.All remaining lots: 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.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.This reported event falls within the scope of a previous corrective action, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this, 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.Upon further investigation, it has been determined that the packaging meets the acceptable criteria specifications and the sterility has not been breached.This event is no longer considered reportable.Therefore, the initial report should be voided 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 12X144MM 4MM T1
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10217373
• Report Number: 0001825034-2020-02606
• Device Sequence Number: 2552285
• Product Code: KWA
• UDI-Device Identifier: 00880304489752
• UDI-Public: (01)00880304489752
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101086
• 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,Followup
• Report Date (Section B): 09/28/2020

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: 05/09/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-104120
• Device Lot Number: 3781142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: NI
• Patient Sequence Number: 1