MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02504, 0001825034 - 2023 - 02505, 0001825034 - 2023 - 02506.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 h3 other text : device location is unknown.

Event Description

It was reported that the patient underwent a revision procedure 16 years post implantation due to pain, elevated metal ion levels and osteolysis.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent a revision procedure 16 years post implantation due to to pain, elevated metal ion levels, and osteolysis.During the revision the surgeon did not identify significant metallic staining of the synovium or the surrounding tissue nor an obvious pseudotumor.Corrosion present on the trunnion was noted.The acetabular cup and head were exchanged without complications.There is no additional 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.G3.G6.H2.H6 mechanical (g04) - stem.H10.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Pre-op diagnosis: right metal on metal total hip arthroplasty with presumed adverse local tissue reaction and elevated serum metal ions.The patient presented with elevated metal ion levels and a mri showing a pseudotumor, combined spinal epidural with periarticular injection, during removal, there was a 2x2 cm cystic defect at the medial aspect of the socket with granulomatous tissue present.There were no intraoperative complications reported.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: UNKNOWN STEM
• Type of Device: PROSTHETIC, 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: 18015055
• MDR Text Key: 326645693
• Report Number: 0001825034-2023-02503
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 01/24/2024
• Supplement Dates FDA Received: 12/21/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD, UNKNOWN LINER, UNKNOWN CUP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male