MAUDE Adverse Event Report: BIOMET UK LTD. EXC ABT STD SHELL HA/PC 050MM; EXCEED ABT CMTLESS CUPS HA/PC

Model Number N/A

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10 - medical devices: unknown liner; item# unknown; lot# unknown.G2 - foreign: poland.The original revision surgery has been reported in a separate complaint.The associated medwatch# are the following: 3002806535 - 2023 - 00217, 3002806535 - 2023 - 00218.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a revision surgery was performed due to dislocation and loosening of the liner.However, while the polyethylene part came out as planned, the metal part remained and could not be removed.The procedure ended with the removal of the acetabular cup and its replacement with a revision one.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that the shell and liner have excessive wear as a result of the dislocated head/stem impinging on the edge of the liner and shell.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Medical radiographs were provided and reviewed by a radiologist: there is superior position of the prosthetic femoral head reflecting severe polyethylene liner wear or displacement.There is no implant loosening or other abnormality.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical devices: e1 tapered std +3mm lnr 32/39; item# e1-003239; lot# unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

• Brand Name: EXC ABT STD SHELL HA/PC 050MM
• Type of Device: EXCEED ABT CMTLESS CUPS HA/PC
• 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: 17296952
• MDR Text Key: 318753016
• Report Number: 3002806535-2023-00219
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 05019279085729
• UDI-Public: (01)05019279085729(17)291111(10)6653417
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 123950HA
• Device Lot Number: 6653417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/13/2023; 09/07/2023
• Supplement Dates FDA Received: 07/27/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.