MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 3 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial surgery, the very experienced surgeon suggested that the final implant was not the same as the trial bearing.Upon switching to another implant of the same size, he found that one to be correct.This confirmed to him that there was an error in the packaging of first implant which he opened.
Event or Problem Description
It was reported that during an initial surgery, the very experienced surgeon suggested that the final implant was not the same as the trial bearing.Upon switching to another implant of the same size, he found that one to be correct.This confirmed to him that there was an error in the packaging of first implant which he opened.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to provide the following additional information: name of the hospital where the procedure was performed: (b)(6) hospital name of the surgeon who performed the procedure: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial surgery, the very experienced surgeon suggested that the final implant was not the same as the trial bearing.Upon switching to another implant of the same size, he found that one to be correct.This confirmed to him that there was an error in the packaging of first implant which he opened.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to provide the following additional information: as the product has not been returned and photographs have not been provided, visual and dimensional evaluations could not be performed.A review of the complaint database over the last 3 years has found no similar complaints for the item #159568.Review of the device history record does not provide any information to suggest the product was not released according to specification.The following evidence has been collated to assess the potential commingle: operation quality provided a list of all parts which were operated on by the same operators in either side of the complaint batch.This identified 7 potential batches which were at the same operation at the same time.The mhrs for the 7 batches were reviewed which showed that all parts were manufactured to pre-defined specification and there were not any discrepancies or deviations which could point to a potential commingle.Lot tracking was run which shows all parts have been distributed therefore it is not possible to return parts for visual and dimensional assessment.A complaint history search for the 8 mhr numbers (including reported complaint mhr) was conducted.There were no complaints reported for any of the potentially affected lot numbers (7 mhrs) or the reported complaint lot number apart from the originating complaint which triggered this investigation.Therefore, in light of the evidence gathered in this assessment, it is concluded that this reported event is unlikely to be due to a commingle, and the parts were distributed conforming to specification.With the information available it is not possible to establish the cause of the reported event.

• Brand Name: OXF ANAT BRG RT SM SIZE 3 PMA
• Common Device Name: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12265890
• Report Number: 3002806535-2021-00335
• Device Sequence Number: 5061645
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: 05019279786145
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2021

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 Expiration Date: 07/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 6814874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 10/06/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/01/2021; 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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