MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHETIC, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).00771101100; femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 standard offset lot number: 62053429.00-6310-050-32; xlpe 10deg poly liner505254x32; lot number: 62092206.00-6202-052-22; tm acet shell 52mm cluster lot number: 62085861.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01717; 0001822565-2023-00153; 0001822565-2023-01719.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Device location is unknown.

Event Description

It was reported that the patient underwent a revision procedure approximately 10 years and 10 months post implantation due to pain, elevated metal ion levels, and metal related pathology.During the procedure a pseudocapsule with thickening, wear, corrosion, bone loss, and bone necrosis were found.The locking ring was also exchanged as it was noted to be unmovable.There were no known complications and no further details are available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h3 h6: proposed component code: mechanical (g04)- head h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.Subsequently, a revision occurred due to pain and elevated metal ions.During the revision, a pseudocapsule was identified, as well as darkening and discoloration of the trunnion.The locking ring was stuck and could not move.The liner was damaged to be removed and a new locking ring was placed.Discoloration and roughening was found within the acetabulum, as well as necrotic bone around the trochanteric region.The head, liner, and locking ring were explanted and replaced with no complications noted.A definitive root cause cannot 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.

Event Description

There is no update to the prior event description provided.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; 1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17238750
• MDR Text Key: 318341875
• Report Number: 0002648920-2023-00138
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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: Lay User/Patient
• Device Expiration Date: 06/27/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 62113219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEAS SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female