MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - XSMALL RIGHT SIZE 4; OXFORD PARTIAL KNEE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial knee arthroplasty the bearing spun out and fell off to the posterior joint capsule side.The surgeon then decided to use a different system, and the femur and tibia components were removed.During removal, the patient¿s femur bone cracked.Surgery was delayed for about 40 minutes.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) concomitant medical devices: oxf ph3 cementless fem sz xsm; item# 154912; lot# 7055221, oxf uni tib tray sz b rm pma; item# 154721; lot# 7083494.Reportv source foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00249, 3002806535-2022-00251.The device will not be returned for analysis; however, an investigation of the reported event is in progress.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 information.D10: medical devices: oxf ph3 cementless fem sz xsm; item# 154912; lot# 7055221.Oxf uni tib tray sz b rm pma; item# 154721; lot# 7083494.Oxf trl brg w/slots xsm 4mm; item# 32-422694; lot# zb130301.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Dimensional analysis determined that the product, where measured, was oversize to print specifications for dimensions a, b and c.This is as expected because the bearing has likely been autoclaved sterilised at the hospital before return and also has been additionally soaked sterilised for 5.5 hours upon return.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - XSMALL RIGHT SIZE 4
• Common Device Name: OXFORD PARTIAL KNEE SYSTEM
• 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: 14629800
• Report Number: 3002806535-2022-00252
• Device Sequence Number: 6169021
• Product Code: NRA
• UDI-Device Identifier: 05019279073023
• UDI-Public: (01)05019279073023(17)260525(10)7029590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 160791
• Device Lot Number: 7029590
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 09/20/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/07/2022; 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female