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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2020

Event Type  Injury  

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, as it remains implanted.Associated products: medical product: oxford ph3 cementless fem sz m; catalog #: 154926; lot #: 6387354.Medical product: oxf uni cmntls tib sz b rm; catalog #: 166573; lot #: 6722361.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

Following an initial partial oxford knee arthroplasty on (b)(6) 2020, it has been reported that the surgeon implanted a left medial bearing instead of a right medial bearing.The bearing remain implanted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: the complaint states: following an initial partial oxford knee arthroplasty on (b)(6) 2020, it has been reported that the surgeon implanted a left medial bearing instead of a right medial bearing.The bearing remains implanted.Event occurred during surgery.Device revision or replacement.No photographs or x-ray images were provided.Complaint could not be confirmed as the part was not returned or any photographic evidence provided.Visual inspection was not carried out as product was not returned for evaluation.Dimensional check was not carried out as the product was not returned for evaluation.No assembly checks were not carried out as product was not returned for evaluation.A review of the raw material certificates was not carried out as this has no impact on the reported complaint.A review of the manufacturing history record shows there were no non-conformances during production and a copy of the label within the mhr shows that the parts were clearly labelled with the correct part/lot numbers and product description (including size and orientation).The associated ifu states that improper selection of implant components may result in unusual stress conditions which may lead to subsequent reduction in service life of the prosthetic components.The root cause is therefore deemed to be due to user error.A review of the manufacturing history record shows that there were no recorded non-conformances during the production of the device and that the device was processed and verified in line with the specification and quality characteristics as defined by zimmer biomet.A review of the raw material certificates was not carried out as this has no impact on the reported complaint.A review of the complaint database did not show any capa or hhed associated to this complaint category.Both the severity and occurrence of the reported event are in line with the risk file.No harm to patient has been reported.The item was distributed conforming.Adequate instructions are provided to ensure the instrument is reprocessed correctly.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered to be low.Capa: no corrective or preventive action required at this time.The investigation is completed based on current available information.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.

Event Description

Following an initial partial oxford knee arthroplasty on (b)(6) 2020, it has been reported that the surgeon implanted a left medial bearing instead of a right medial bearing.The bearing remain implanted.

Manufacturer Narrative

(b)(4) adverse event problem update: 19 - cause traced to user 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.

Event Description

Following an initial partial oxford knee arthroplasty on (b)(6)2020, it has been reported that the surgeon implanted a left medial bearing instead of a right medial bearing.The bearing remains implanted.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12119802
• MDR Text Key: 260007269
• Report Number: 3002806535-2021-00295
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 6781073
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other