MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 3 PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Pain (1994); No Information (3190)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Initial report source: report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being 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 Description

It was reported that a patient underwent an initial right knee arthroplasty on an unknown date in 2012.Subsequently, a revision procedure due to implant fracture was performed on november 16th, 2020.Bearing fracture.Poly worn very thin prior to fracture.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: product numbers received.D11: medical product: 166579, catalog #: oxf uni cmntls tib sz e rm, lot #: 2248367.Medical product: 154927, catalog #: oxford ph3 cementless fem sz l, lot #: 2330698.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on an unknown date in 2012.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2020.Bearing fracture.Poly worn very thin prior to fracture.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on an unknown date in 2012.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2020.Bearing fracture.Poly worn very thin prior to fracture.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.On visual inspection it was confirmed that the polyethylene bearing was received in two fragments.The meniscal bearing received with (b)(4) was measured with a digital caliper and compared to the nominal dimensions in the relevant engineering drawing.The anterior aspect of the component was found above the specified tolerance; an increase in bearing thickness has been observed in autoclaved polyethylene components, therefore this is compatible with the fact that the part was autoclaved by the hospital.The thickness of the posterior aspect was measured at the thinnest point, and it was found to have reduced below the tolerances defined in the engineering drawing.The thickness of the central region of the bearing, measured on the posterior fragment, was also found to have reduced below the defined tolerances assembly check not applicable for the reported event as the bearing was fractured and neither tray or femoral were returned.A right oxford anatomic bearing was revised due to fracture after approximately 8 years in use.The component was received fractured in two fragments, both presenting extensive wear and damage, in particular to the posterior lateral corner and to the posterior portion of the inferior articulating surface.The thickness of the central region was found to have reduced during service by 0.78 mm below its nominal thickness, indicating a wear rate of approximately 0.1 mm/year.Three images with a total of six radiographs were provided with (b)(4), two pre-revision anteroposterior (ap) radiographs taken on an unknown date; two pre-revision ap fluoroscopy images taken on (b)(6) 2020; two post-revision radiographs, one ap and one mediolateral (ml), taken on (b)(6) 2020.An assessment of these radiographs has been carried out.However, immediate post-primary radiographs are required to assess the initial sizing, positioning and alignment of components.These have been requested, but were taken at a different hospital and could not be obtained.The root cause of the oxford bearing fracture could not be confirmed in this instance without additional patient information and notes from the primary surgery and post-primary radiographs.However, it is possible that suboptimal sizing, positioning and alignment of components, as well as patient¿s activity, may have resulted in unusual stress conditions that may have led to the subsequent reduction in service life of the component.The bearing and associated components were manufactured and sterilized in accordance with the applicable specifications.From the information currently available there is no evidence to suggest that the product left the company non-conforming to specification at the time of manufacture or regulatory compliance.A review of the manufacturing history records confirms no abnormalities or deviations reported for 159582.Bearing was manufactured on august 14, 2008.Implant has been in the field for approximately 12 years and 9 months.It was reported that a patient underwent an initial right knee arthroplasty on an unknown date in 2012.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2020.No non-conformances were identified from the available information after mhr review.Lot.No.1565387 has not been involved in any previous field actions.No corrective or preventive action is considered necessary at this time.As per cemented oxford knee risk management report, the severity of the reported event and calculated occurrence for similar complaints are in line with the risk file.The risk is deemed as low.

• Brand Name: OXF ANAT BRG RT LG SIZE 3 PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11063582
• MDR Text Key: 223356375
• Report Number: 3002806535-2020-00555
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 159582
• Device Lot Number: 1565387
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention