MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD MEDIAL UNICOMPARTMENTAL KNEE; UNKNOWN KNEE ARTHROPLASTY

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation (product location unknown).Patients information were not reported.Otal of 115 patients, 16 males and 99 females (age range: 50 to 88).Among them, 1 patient underwent revision surgery due medial collateral ligament deficiency.Authors information: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unknown location of the device.

Event Description

Information received based on journal article entitled the long-term results of cemented oxford unicompartmental knee arthroplasty: a single-center experience that 156 patients underwent oxford medial unicompartmental knee arthroplasty (uka).However, five of these patients died during the study and 36 patients could not be reached at the final follow-up visit.Revision surgeries were performed for all these patients.Total of 115 patients, 16 males and 99 females (age range: 50 to 88).Among them, 1 patient underwent revision surgery due to medial collateral ligament deficiency.This complaint reports the revision due to medial collateral ligament deficiency.

Event Description

Information received based on journal article entitled the long-term results of cemented oxford unicompartmental knee arthroplasty: a single-center experience that 156 patients underwent oxford medial unicompartmental knee arthroplasty (uka).However, five of these patients died during the study and 36 patients could not be reached at the final follow-up visit.Revision surgeries were performed for all these patients.Total of 115 patients, 16 males and 99 females (age range: 50 to 88).Among them, 1 patient underwent revision surgery due to medial collateral ligament deficiency.This complaint reports the revision due to medial collateral ligament deficiency.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in turkey.Biomet uk ltd have attempted to contact the journal article author, however, the author has informed that no further information is available.The product has not been returned to biomet uk ltd for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Trend analysis could not be performed as product numbers are not available.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: UNKNOWN OXFORD MEDIAL UNICOMPARTMENTAL KNEE
• Type of Device: UNKNOWN KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10042080
• MDR Text Key: 191588586
• Report Number: 3002806535-2020-00242
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• 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