MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA LM; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 surgery, it would discovered that the sterile packaging was ripped on the side.
Additional Manufacturer Narrative
(b)(4).Adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified no additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.These part and lot combinations are not associated with any recalls or field actions at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and packaging has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event can not be determined with the information provided.Corrective or preventative action not required.The root cause of the reported event can not be determined with the information provided.
Event or Problem Description
It was reported that during surgery, it would discovered that the sterile packaging was ripped on the side.

• Brand Name: OXF UNI TIB TRAY SZA LM
• Common Device Name: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12597902
• Report Number: 3002806535-2021-00439
• Device Sequence Number: 19901222
• Product Code: NRA
• UDI-Device Identifier: 05019279388844
• UDI-Public: 05019279388844
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 09/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 154718
• Device Lot Number: 2829083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown