MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI CMNTLS TIB SZ C LM; PROSTHESIS, KNEE

Catalog Number	166574
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: associated medical devices: oxf anat brg lt md size 3 pma; item# 159547; lot# 67165060 x2, oxf anat brg lt md size 3 pma; item# 159547; lot# 67118949 x2.G2: foreign: event occurred in china.2 products lot # 67165060 have been returned.Visual examination of the first product found that the bearing was still sealed within the cavity with the seal intact.Visual examination of the second product identified that the bearing moves freely within the pouch.The vacuum sealed pouch is wrinkled with creases and folds.It was no longer vacuum sealed.The pouch was sent for further analysis by virtue of a bubble test.The test passed confirming that the pouch is not breached.2 products lot # 67118949 have been returned.Visual examination of the first product found that the bearing was still sealed within the cavity with the seal intact.Visual examination of the second product identified that the bearing moves freely within the pouch.The vacuum sealed pouch is wrinkled with creases and folds.It was no longer vacuum sealed.The pouch was sent for further analysis by virtue of a bubble test.The test passed confirming that the pouch is not breached.1 product lot # 6728016 has been returned.Visual examination found that the oxford tibial component moves freely within the pouch.The vacuum sealed pouch is wrinkled with creases and folds and has a visible small hole (tear).It was no longer vacuum sealed.A review of the device manufacturing records of lots # 67165060 and 6728016 confirmed no abnormalities or deviations that could be related to the reported event.A review of the device manufacturing records of lot # 67118949 confirmed no abnormalities or deviations.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.On the five returned products, two bearings were still sealed within the cavity with the seal intact.For these two products, it is considered that the root cause of the reported issue is unrelated to the zimmer biomet medical device.The three other products (two bearings and one tibial component) moves freely within the pouch which was no longer vacuum sealed.For the two bearings pouches, testing confirmed that pouches were not breached and were sealed within validated parameters ensuring the products remain protected and safe for use.It is therefore considered that the products were packaged to pre defined specification and no manufacturing or design issue was identified.The root cause of the reported issue is attributed to a transport/storage issue.Regarding the tibial component pouch, a visible small hole was found during visual inspection.However, a definitive root cause of this hole could not be determined.Furthermore, review of the device manufacturing histories indicate that the products were packaged to pre-defined specification and no manufacturing or design issue was identified.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
It was reported that during a procedure, upon opening the package, the surgeon observed that the inner sterile packaging was not vacuum sealed.Five packages in total from different batches were opened and reportedly exhibited the same condition.It was unclear whether the issue was due to a packaging damage or a potential design change.There were no reported adverse consequences or patient impact, and the procedure was completed using back-up implants.No further event information is available at the time of this report.

• Brand Name: OXFORD UNI CMNTLS TIB SZ C LM
• Common Device Name: PROSTHESIS, KNEE
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24468434
• Report Number: 3002806535-2026-00100
• Device Sequence Number: 21363821
• Product Code: NRA
• UDI-Device Identifier: 00887868354731
• UDI-Public: (01)00887868354731(17)300218(10)6728016
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/27/2026

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: 166574
• Device Lot Number: 6728016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• 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: 02/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown