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 Problem Corroded (1131)

Patient Problem Failure of Implant (1924)

Event Date 10/22/2018

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial hip procedure and was revised approximately ten years later due to corrosion of the head and stem.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cat# 00620005422, lot# 61079419 shell porous with cluster holes 54 mm o.D.Cat# 00631005032, lot# 61049684 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells.Cat# 00625006540, lot# 61077248 bone scr 6.5x40 self-tap.Cat# 00625006520, lot# 61070811 bone scr 6.5x20 self-tap.H6: proposed component code: mechanical (g04)- head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03164.Visual examination of the returned product identified dark debris and a circumferential groove pattern is seen on surface of the conical taper of the head.The stem remains implanted.The head was submitted for further analysis.Analysis determined a consensus modified goldberg score of 3.A score of 3 corresponds to ¿fretting on >30% of the surface and/or aggressive local corrosion attack with corrosion debris" review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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.

• 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
• 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: 17959318
• MDR Text Key: 325970535
• Report Number: 0002648920-2023-00254
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2023

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: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 61074146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2008
• 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): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose