MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED FULLCOAT 12/14 NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip revision due to metallosis, and damage to the abductor and short external rotator muscles approximately 9 years post implantation.During the revision, as the acetabulum was well fixed, the locking ring broke while trying to be removed.The stem and shell were left intact, and all other components were replaced.Large amount of clear synovial fluid drained from hip joint and synovial tissue and muscle stained yellow with chronic fibrous changes due to metallosis process.No further complications were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Medical products: ref 8018-36-04 lot 62136705 femoral head; ref 6200-58-22 lot 61996714 shell porus 58mm; ref 6305-58-36 lot 61736838 liner standard 3.5mm offset 36mm; ref 00-7843-013-56 lot 61710265 imp versys 6 headed fc 13x160mm lm body ext neck.Multiple reports were submitted along with this report 0002648920-2022-00157 and 0002648920-2022-00158.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.The following sections were updated/corrected updated: b4, b5, d4, g3, g6, h2, h3, h6, h10 corrected: d4: udi#: not applicable h6: component code: mechanical (g04)-stem medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision due to metallosis and elevated metal ions.During the revision, significant damage was found to the surrounding muscles and tissues of the left hip.Additionally, pitting was found on the trunnion of the stem, but was deemed acceptable to remain implanted.While attempting to remove the liner, it was found the locking ring was stuck in place and was broken in order to remove it.A new zimmer head, locking ring, and liner were implanted with no complications noted.Device history record was reviewed and no discrepancies relevant 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL STEM BEADED FULLCOAT 12/14 NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15041260
• MDR Text Key: 296057899
• Report Number: 0001822565-2022-02046
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973714
• 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
• Report Date: 09/26/2022

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00784301356
• Device Lot Number: 61710265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male