MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problems Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported patient underwent a right hip revision approximately 12 years post implantation due to pain.During the surgery a pseudocapsule was encountered, gross corrosion was noted at the trunnion and acetabulum components, and the gluteus medius damaged from previous surgery.The head and liner were removed and replaced without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803201 ¿ cocr head ¿ 60939983, 00771100900 ¿ m/l taper stem ¿ 60939440, 00620205622 ¿ trabecular metal shell ¿ 60548425, 00625006530 ¿ bone screw- 60875832, 00630505632 ¿ liner ¿ 60918074.Medical records were reviewed by an hcp and notes revision due to pain.Pseudocapsule in the joint and corrosion at the trunnion and screw holes of the shell.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021 -00310, 0001822565 -2021 -02832, 0001822565 -2022 -00348, 0002648920 -2022 -00022.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
• 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: 13451336
• MDR Text Key: 285056742
• Report Number: 0002648920-2022-00023
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 60740475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2007
• 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: Female