MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN CEMENTED UKR; UNKNOWN HIP ARTHROPLASTY

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

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 (product location is unknown).Medical product: unknown cementless ukr, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00517.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

We have received a manuscript, which reports the following; the aim of this study was to compare clinical outcomes for 262 cementless and 262 cemented medial ukr with an appropriately powered study.In order to ensure any difference was due to the fixation, the oxford® partial knee, which otherwise has identical cemented and cementless components, was studied, and the ukr were implanted by high volume surgeons, using identical indications and technique.There were no significant differences between the cohorts for demographics, pre-operative scores, and 5-year revision rate (0.8%), re-operation rate (1.5%), and complication 17 rate (5%).The cementless cohort had significantly better 5-year oks, the pain/discomfort had the largest and the most significant difference.Various revision procedures and re-operations are listed in the study: revisions in the cemented cohort: bearing dislocation x1.Conversion to tkr for lateral compartment arthritis x1.Revisions in the cementless cohort: conversions to tkr for lateral compartment arthritis x2.Re-operations in cemented cohorts: arthroscopies x3.Washouts x1.Re-operations in cementless cohorts: arthroscopies x2.Washouts x1.Manipulation-under-anaesthetic x1.There were also 12 recorded medical complications in the cemented cohort and 13 in the cementless cohort.No patients died for reasons directly or indirectly relating to their knee replacement.The study demonstrates that the cementless ukr is associated with better clinical outcomes than cemented ukr, which is primarily due to improved pain relief.Both cemented and cementless ukr are safe with low reoperation and complication rates and a 5-year survival of 99%.

Event Description

We have received a manuscript, which reports the following; the aim of this study was to compare clinical outcomes for 262 cementless and 262 cemented medial ukr with an appropriately powered study.In order to ensure any difference was due to the fixation, the oxford® partial knee, which otherwise has identical cemented and cementless components, was studied, and the ukr were implanted by high volume surgeons, using identical indications and technique.There were no significant differences between the cohorts for demographics, pre-operative scores, and 5-year revision rate (0.8%), re-operation rate (1.5%), and complication17 rate (5%).The cementless cohort had significantly better 5-year oks, the pain/discomfort had the largest and the most significant difference.Various revision procedures and re-operations are listed in the study: revisions in the cemented cohort: bearing dislocation x1.Conversion to tkr for lateral compartment arthritis x1.Revisions in the cementless cohort: conversions to tkr for lateral compartment arthritis x2.Re-operations in cemented cohorts: arthroscopies x3.Washouts x1.Re-operations in cementless cohorts: arthroscopies x2.Washouts x1.Manipulation-under-anaesthetic x1.There were also 12 recorded medical complications in the cemented cohort and 13 in the cementless cohort.No patients died for reasons directly or indirectly relating to their knee replacement.The study demonstrates that the cementless ukr is associated with better clinical outcomes than cemented ukr, which is primarily due to improved pain relief.Both cemented and cementless ukr are safe with low reoperation and complication rates and a 5-year survival of 99%.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00517-1.As the product has not been received, the investigation was limited to the information provided.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.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Follow-ups were sent to obtain more information, however, it was communicated that no further information is available.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.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: UNKNOWN CEMENTED UKR
• Type of Device: UNKNOWN HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10958137
• MDR Text Key: 221477235
• Report Number: 3002806535-2020-00516
• Device Sequence Number: 1
• Product Code: KWY
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• 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