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

Catalog Number 00771101520

Device Problems Material Erosion (1214); Unintended Movement (3026); Noise, Audible (3273)

Patient Problems Pain (1994); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item#: 00801802814/femoral head / lot #: 62542708.Item #: 00875801228 / liner/lot # 61675526.Item#: 00875705601/ shell/ lot# 61903786.Item #: 00625006540/bone screw /lot # 62462616.Item #: 00625006530, bone screw/ lot # 61911788.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01300, 0001822565 -2020 -01301, 0001822565 -2020 -01302.

Event Description

It was reported patient underwent hip revision surgery 4 years post implantation due to pain and squeaking.During the revision, metal debris was noted from the femoral neck impinging on the metal ring of the locking liner.The shell, head, and liner were replaced without complication, and another attempt to repair the abductors was made.Attempts have been made and additional information on the reported event is unavailable at this time.

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.The following sections were updated/corrected updated: g4; h2; h3; h6.D4:(b)(4).Review of medical records indicated.Patient underwent initial tha and has since undergone a closed reduction and three revisions of the head and liner for pain, instability and dislocation.Patient underwent fourth revision due to pain and squeaking.During the procedure it was noted that the abductors were found to be off of the trochanter and metal debris was present.The squeaking came from the femoral neck impinging on the metal ring of the constrained liner.The shell, head, and liner were replaced and leg lengths made equal.Metal debris was debrided and irrigated.Surgeon repaired what he could of abductors.Metal ion levels were elevated after this revision however lab results show that overall the levels are decreasing.Chromium levels dropped from 1.2 to below 1 and cobalt levels dropped from 10.1 to 5.0.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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 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: 9932946
• MDR Text Key: 190045516
• Report Number: 0001822565-2020-01298
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 00771101520
• Device Lot Number: 61712783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 169