MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT MD SIZE 3 PMA; KNEE PROSTHESIS

Catalog Number	159547
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2: foreign: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the air-filled sterile packaging was not in order.No patient involvement.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
It was reported that there was a hole in air-filled sterile packaging.No patient involvement.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h6, h11.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d1, d9, g3, g6, h2, h3, h6, h10, h11.The following sections were updated: g1-2.Product was returned and visually assessed which did identify creases in the pouch material but did not identify that the pouch has been breached it was therefore sent for further analysis by virtue of a bubble test.The test passed confirming that the pouch is not breached.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item.The root cause of the reported issue is unrelated to the zimmer biomet medical device.Whilst some wrinkling of the pouch can occur during packaging and shipping, this does not affect the product or the package integrity.Most importantly, testing confirmed that pouch was not breached and was sealed within validated parameters ensuring the product remains protected and safe for use.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: OXFORD ANAT BRG LT MD SIZE 3 PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21189808
• Report Number: 3002806535-2025-00007
• Device Sequence Number: 20990283
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: (01)05019279785933(17)290612(10)66711928
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2025

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 Catalogue Number: 159547
• Device Lot Number: 66711928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 01/22/2025; 09/19/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 01/24/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown