MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT X-SM SZ 6 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	08/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.Associated products: medical product: oxf ph3 cementless fem sz xsm.Catalog no.: 154912.Lot no.: 3727339.Medical product: oxf uni cmntls tib sz a lm.Catalog no.: 166845.Lot no.: 3259236.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unavailable by hospital policy.
Event or Problem Description
It was reported, that: patient complained of knee giving away over the weekend of the (b)(6).Presented to emergency department, where x-rays revealed loose bearing.No fall reported.Patient involvement.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no reported abnormalities or deviations.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 159793.The severity of the reported event is in line with the risk file without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : unavailable by hospital policy.
Event or Problem Description
It was reported, that: patient complained of knee giving away over the weekend of the 28./29 august.Presented to emergency department, where x-rays revealed loose bearing.No fall reported.Patient involvement.

• Brand Name: OXF ANAT BRG LT X-SM SZ 6 PMA
• Common Device Name: OXFORD HXLPE BEARINGS
• 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: 12517713
• Report Number: 3002806535-2021-00390
• Device Sequence Number: 4460111
• Product Code: NRA
• UDI-Device Identifier: 05019279068968
• UDI-Public: 05019279068968
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 12/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2017
• Device Model Number: N/A
• Device Catalogue Number: 159793
• Device Lot Number: 2721968
• 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: 08/31/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 63 KG