MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - SMALL LEFT SIZE 4; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf twin-peg cmntd fem sm pma item#161468 lot#533960, oxf uni tib tray sz b lm pma item#154720 lot#775070.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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00258, 3002806535-2022-00259.

Event Description

It was reported that the patient underwent a revision surgery due to unknown reason, approximately 3 years post-op.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at time of this report, due diligence is complete.As multiple attempts were made.

Manufacturer Narrative

This follow-up report is being submitted, to relay additional information.Visual and dimensional evaluations could not be performed, as no product was returned.Nor were pictures provided.Device history record was reviewed, and no discrepancies related to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed.The definitive root cause of the reported event cannot be determined, with the information provided.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 - SMALL LEFT SIZE 4
• Type of Device: 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: 14560645
• MDR Text Key: 293075804
• Report Number: 3002806535-2022-00254
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785872
• UDI-Public: (01)05019279785872(17)221019(10)017210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 017210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male