MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD NON-SKIRTED 12/14 TAPER; PROSTHESIS HIP

Catalog Number 00801802814

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 location is unknown.(b)(4).Concomitant medical products: item # 00771101520/ femoral stem neck taper/ lot # 61712783.Item# 00875801228/ liner / lot #61675526.Item# 00875705601/ shell/ lot# 61903786.Item # 00625006540/bone screw /lot # 62462616.Item # 00625006530 bone screw/ lot # 61911788.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01298.0001822565 -2020 -01302.0001822565 -2020 -01301.

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.

• Brand Name: FEMORAL HEAD NON-SKIRTED 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10138985
• MDR Text Key: 194671506
• Report Number: 0002648920-2020-00299
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 00801802814
• Device Lot Number: 62542708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 169