MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN CERAMIC HEAD 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 exceed abt ceramic liner, catalog #: unknown, lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00479. 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.

• Brand Name: UNKNOWN CERAMIC HEAD
• Type of Device: UNKNOWN HIP ARTHROPLASTY
• 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: 10851928
• MDR Text Key: 216850939
• Report Number: 3002806535-2020-00480
• Device Sequence Number: 1
• Product Code: KWY
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• 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

• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 11/17/2020 Patient Sequence Number: 1