MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SELEX/MAGNUM MOD HD 40MM -3; PROSTHESIS, HIP

Catalog Number S031140

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 07/06/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent left hip arthroplasty.Subsequently, the patient was revised approximately 13 years post implantation due to radiographic osteolysis.During the procedure a pseudocapsule, hypertrophic villous synovium, scar tissue and granulomatous tissue were all excised.It was noted that corrosive debris was found on the taper, and the head and taper were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: cup: 0001825034-2022-02123, fmrl: 0001825034-2022-02125.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02123-1.0001825034-2022-02125-1.H6: mechanical (g04) head.This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided pictures identified there is a dark discoloration present on the stem and in the head taper.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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 additional event information to report at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified it appears to have some type of residue all over outside of the modular head and in the taper and does seem to have wear and damage from extraction.Additionally, the head was sent for additional testing.The taper was determined to have evidence of corrosive attack and abundant corrosion debris.The additional information does not change the outcome of the previous investigation.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.

• Brand Name: SELEX/MAGNUM MOD HD 40MM -3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15418077
• MDR Text Key: 299863893
• Report Number: 0001825034-2022-02124
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: S031140
• Device Lot Number: 743640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 02/20/2023
• Supplement Dates FDA Received: 09/27/2022; 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• 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: CAT #: 14-103202 FMRL.LOT #: 018440.; CAT #: US157846 CUP.LOT #: 451630.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male