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

Model Number N/A

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

Patient Problems Pain (1994); Scar Tissue (2060); Reaction (2414)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: cat# 00771101100 femoral stem 12/14 neck taper lot# 61371698, cat# 00620005822 shell porous with cluster holes 58 lot# 61407910, cat# 00631005832 liner 10 degree elevated lot# 61375210, cat# 00625006530 bone scr 6.5x30 self-tap lot# 61422326.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03441.

Event Description

It was reported a patient had underwent a left hip revision approximately 8 years post implantation due to elevated metal ion levels, pain, in-vivo corrosion, and scar tissue.No additional information.

Event Description

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

Manufacturer Narrative

The reported event was confirmed by review of medical records noting patient had elevated metal ion levels.Scar tissue was excised from the wound during the procedure and there was corrosion at the head-trunnion interface.No evidence of alval was found.The head was removed and replaced.Dhr was reviewed and no discrepancies were found.The root cause is 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 HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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
• MDR Report Key: 10642616
• MDR Text Key: 210232113
• Report Number: 0002648920-2020-00447
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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: 02/13/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801803203
• Device Lot Number: 61409524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91