MAUDE Adverse Event Report: BIOMET UK LTD. RECAP/MAGNUM CEMENTLESS ACETABULAR SHELL 56/50MM; HIP PROTHESIS

Model Number N/A

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Synovitis (2094); Metal Related Pathology (4530)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - m2a-magnum mod hd sz 50mm, item# 157450, lot# 1505536; tprloc 12/14 por lat 11x142, item# 650-0264, lot# 1476477; magnum tpr adpr ti 42- 50/+8mm, item# 130832, lot# 1338003.G2 ¿ foreign ¿ italy.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent an initial left mom hip surgery.Approximately nine years post-implantation follow up examinations resulted in elevated metal ion levels.Due diligence is in progress for this complaint; to date no additional information or product has been received.

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 and/or corrected information.The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.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.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: RECAP/MAGNUM CEMENTLESS ACETABULAR SHELL 56/50MM
• Type of Device: HIP PROTHESIS
• 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: 16929118
• MDR Text Key: 315181113
• Report Number: 3002806535-2023-00137
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 05019279927630
• UDI-Public: (01)05019279927630(17)180508(10)1488514
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2018
• Device Model Number: N/A
• Device Catalogue Number: 157856
• Device Lot Number: 1488514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2008
• 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.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 110 KG