MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN EXCEED ABT CERAMIC LINER; UNKNOWN HIP ARTHROPLASTY

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  

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.Concomitant medical devices: medical product: unknown ceramic head, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00480.Postal code: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.

Event Description

Information received based on review of a journal article, entitled independent assessment and outcomes of 196 short-tapered stems short-term follow-up and review of the literature by sam nahas, akash patel, nicola blucher and vikas vedi et al.(2018).A journal article was retrieved from the journal of orthopaedic surgery (2018) that reported a retrospective single case series from the united kingdom that looked at assessment and outcomes of short-tapered stems.The purpose of the study was to assess the primary and secondary outcome of cementless microplasty taperloc stems.The study reviewed one hundred ninety-seven total hip arthroplasties (tha).One hundred five were males and ninety-one were females.All patients underwent implantation by a single consultant orthopaedic surgeon utilizing the microplasty taperloc stem in combination with the biomet exceed abt cup system all patients receiving a ceramic on ceramic bearing via the posterior approach.The study population had a mean age of 59 years at time of surgery (range 21-78).Follow-up was conducted at 6 six weeks, twelve months, and annually thereafter with a mean length of follow-up for 36 months (range 5-75).The study reported one patient who experienced a dislocation two years post-operatively and was treated with closed reduction.

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: 3002806535-2020-00480-1.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.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.

Event Description

Information received based on review of a journal article, entitled independent assessment and outcomes of 196 short-tapered stems short-term follow-up and review of the literature by sam nahas, akash patel, nicola blucher and vikas vedi et al.(2018) a journal article was retrieved from the journal of orthopaedic surgery (2018) that reported a retrospective single case series from the united kingdom that looked at assessment and outcomes of short-tapered stems.The purpose of the study was to assess the primary and secondary outcome of cementless microplasty taperloc stems.The study reviewed one hundred ninety-seven total hip arthroplasties (tha).One hundred five were males and ninety-one were females.All patients underwent implantation by a single consultant orthopaedic surgeon utilizing the microplasty taperloc stem in combination with the biomet exceed abt cup system all patients receiving a ceramic on ceramic bearing via the posterior approach.The study population had a mean age of 59 years at time of surgery (range 21-78).Follow-up was conducted at 6 six weeks, twelve months, and annually thereafter with a mean length of follow-up for 36 months (range 5-75).The study reported one patient who experienced a dislocation two years post-operatively and was treated with closed reduction.This incident reports the dislocation, which was resolved with a closed reduction.

• Brand Name: UNKNOWN EXCEED ABT CERAMIC LINER
• Type of Device: UNKNOWN HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10851923
• MDR Text Key: 216852362
• Report Number: 3002806535-2020-00479
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: 11/25/2020
• 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