MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/28/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown unknown head lot #: unknown, item #: unknown unknown stem lot #: unknown, item #: unknown unknown liner lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04348 head, 0001822565 - 2019 - 04349 stem, 0001822565 - 2019 - 04351 liner.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported by legal counsel that a patient underwent a right hip arthroplasty and was revised five years later due to unknown reasons.Attempts were made to obtain additional information; however, none was available.

Event Description

It was reported patient underwent primary right total hip arthroplasty.Subsequently; patient experienced pain and elevated cobalt levels.The patient was revised approximately five years post implantation.Surgeon noted corrosion and difficulty removing poly liner and notes post removal of liner, damage to metal cup and locking mechanism.Head, liner and cup revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2; a4; b1; b5; b7; d2; d4; h2; h3; h4; h6 corrected: d1; d4; g5 d11: versys femoral head -3.5 (00-8018-040-01, 61138115) trilogy acetabular shell (00-6200-060-22, 61157327) trilogy longevity acetabular liner (00-6305-060-40, 61068497) bone screw (00-6250-065-35, 61138004) reported event was confirmed by review of medical records received.Review of the available records identified the patient underwent an initial right hip arthroplasty during which zimmer biomet products were implanted without complications.The patient was revised due to pain and elevated metal ions.Blood work showed elevated cobalt levels - 5; (b)(6) 2014 - 4.5.Mri showed the presence of altr.Corrosion was noted at the head/ neck junction.Surgeon had difficulty removing the liner using osteotomes, and the cup was damaged proximally after removal of the liner.The cup, liner, and head were removed.New zimmer biomet products were implanted.No other findings/ complications were noted.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The difficulty experienced in removing the liner from shell can be attributed to use error / surgical technique not being followed.Zimmer biomet¿s surgical technique states that appropriate disassembly devices - disassembly device (pn 00-6260-030-01) and liner extractor (pn 00-6260-035-0) should be utilized to remove the liner from the shell.However, the root cause for the other reported issues could not be determined.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9176189
• MDR Text Key: 162524166
• Report Number: 0001822565-2019-04350
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 65771101100
• Device Lot Number: 60894848
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 147