MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXF MOBILE BEARING

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Event Description

It was reported, that: management of aseptic failure of the mobile-bearing oxford unicompartmental knee arthroplasty.Main complaint description: on 15-sep-2021, a journal article was retrieved from the knee (2020) that reported a study from the (b)(6) that looked at aseptic revisions in unicompartmental knee arthroplasties.The purpose of the study was to understand the revision strategies and clinical outcomes for aseptic failed ukas.The study reviewed 48 patients (31 female, 17 male)/52 knees revised from 2006 to 2018 at a single facility.All failed implants were mobile-bearing oxford ukas, comprising 47 medial ukas (bridgend) and five lateral ukas (warsaw).Fifty ukas (96.2%) were cemented and two (3.8%) were uncemented.The median time to revision was 67 (range 4¿180) months.Indications for revision were progression of osteoarthritis (n = 31 knees, 59.6%), unexplained pain (n = 10 knees, 19.2%), aseptic loosening (n = 6 knees, 11.5%), medial collateral ligament incompetence (n = 3 knees, 5.8%) and recurrent bearing dislocation (n = 2 knees, 3.8%).Failed ukas were revised to primary tkas (n = 29 knees, 55.8%), revision tkas (n = 9 knees, 17.3%), bicompartmental kas (n = 11 knees, 21.2%), or unicompartmental-to-unicompartmental kas (n = 3 knees, 5.8%).Median follow up was 81 (range 24¿164) months.The study population had a mean age of 65 years at the time of surgery (range 31.9-84.2 years).Complaint one: the study reported that two patients underwent revision due to recurrent bearing dislocation.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in the (b)(6).As the complaint is derived from a journal article, there is insufficient information to know if the device will be returned to zimmer biomet.If the device is to return this will be passed via a supplemental report.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay information.D9: the product will not be returned to zimmer biomet for an investigation as the product location is unknown.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.These devices are used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.Unable to perform previous field action search as item and lot number have not been provided.The likely condition of the devices when they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action required at this time as the root cause of the reported event has not been determined.

Event Description

Title: management of aseptic failure of the mobile-bearing oxford unicompartmetal knee arthroplasty.Authors: shiraz a.Sabah, chin tat lim, robert middleton, lennart von fritsch, nicholas bottomley, william f.M.Jackson, andrew j.Price , abtin alvand.Published 07 october 2020.On 15-sep-2021, a journal article was retrieved from the knee (2020) that reported a study from the united kingdom that looked at aseptic revisions in unicompartmental knee arthroplasties.The purpose of the study was to understand the revision strategies and clinical outcomes for aseptic, failed ukas.The study reviewed 48 patients (31 female, 17 male) / 52 knees revised from 2006 to 2018 at a single facility.All failed implants were mobile-bearing oxford ukas, comprising 47 medial ukas (bridgend) and five lateral ukas (warsaw).Fifty ukas (96.2%) were cemented and two (3.8%) were uncemented.Median time to revision was 67 (range 4¿180) months.Indications for revision were progression of osteoarthritis (n = 31 knees, 59.6%), unexplained pain (n = 10 knees, 19.2%), aseptic loosening (n = 6 knees, 11.5%), medial collateral ligament incompetence (n = 3 knees, 5.8%) and recurrent bearing dislocation (n = 2 knees, 3.8%).Failed ukas were revised to primary tkas (n = 29 knees, 55.8%), revision tkas (n = 9 knees, 17.3%), bicompartmental kas (n = 11 knees, 21.2%), or unicompartmental-to-unicompartmental kas (n = 3 knees, 5.8%).Median follow up was 81 (range 24¿164) months.The study population had a mean age of 65 years at time of surgery (range 31.9-84.2 years).The study reported that two patients underwent revision due to recurrent bearing dislocation.

• Brand Name: UNK OXF MOBILE BEARING
• Type of Device: UNK OXF MOBILE BEARING
• 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: 13583196
• MDR Text Key: 290544997
• Report Number: 3002806535-2022-00080
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK OXF MOBILE BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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