MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Local Reaction (2035); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00630506240, liner standard 3.5 mm, 61817101; 00771101120, femoral stem 12/14, 61904690; 00620006222, shell porous, 61976148.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01474, liner; 0001822565-2021-00464, stem.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: the patient underwent an initial right total hip arthroplasty on due to degenerative arthritis during when, zimmer biomet products were implanted without complications.The patient underwent a revision procedure due to failed hip arthroplasty.The patient had a recent dislocation and was worked up for metal debris.His cobalt and chromium levels were high, and mri scan revealed a large pseudotumor.There was corrosion at the head-trunnion junction.No other findings/complications related to the event were noted.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

It was reported the patient underwent a right hip revision approximately 8 years post implantation due to in-vivo corrosion, dislocation, adverse local tissue reaction (altr), elevated metal ion levels, and pseudotumor.The acetabular liner and femoral head were removed and replaced.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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

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.Reported event was confirmed due to the review of medical records.Additional medical records were provided: the patient experienced a right hip dislocation that was corrected with a closed reduction.The revision procedure occurred.Upon completion, a new zimmer head and liner were placed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause remains unchanged.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

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

• Brand Name: FEMORAL HEAD STERILE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11920002
• MDR Text Key: 253717271
• Report Number: 0002648920-2021-00141
• Device Sequence Number: 1
• Product Code: JDI
• 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: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801804002
• Device Lot Number: 62036519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 01/04/2021; 02/10/2022
• Supplement Dates FDA Received: 01/19/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG