MAUDE Adverse Event Report: BIOMET UK LTD. EXCEED ABT 3HL SHELL 44/54MM; HIP ARTHROPLASTY

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: medical product: delta cer fm hd, catalog #: 650-0837, lot #: 2015020758, medical product: biolox delta lnr, catalog #: 650-0795, lot #: 3510003, medical product: ppf ltz stem bmstr, catalog #: 71-001-00305bm, lot #: 2015020924.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00025, 3002806535-2020-00027.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported by the patient's legal representative that the patient allegedly experienced unknown damages.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00025-1, and 3002806535-2020-00027-1.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : devices remain implanted.

Event Description

It has been reported by the patient's legal representative that the patient allegedly experienced unknown damages.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

• Brand Name: EXCEED ABT 3HL SHELL 44/54MM
• Type of Device: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9595545
• MDR Text Key: 175186080
• Report Number: 3002806535-2020-00026
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 124454
• Device Lot Number: 3505390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other