MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER 32 MM DIAMETER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of revision operative notes and product received.The taper surface on the femoral head and stem note dark debris consistent with taper corrosion.Debris was noted on the external articulating surface of the head.Sem images confirmed the presence of dark debris on the femoral head taper operative notes stated patient had adverse local tissue reaction.During procedure abundant amount of fluid under pressure that was in trochanteric bursa.A hole in the posterior capsular found.Some debris in the fluid, but was not cloudy.A mid amount of corrosion inside the head was noted.There was some adverse local tissue reaction behind the shell with some bone loss.There was some osteolysis around the proximal portion of the femoral component.Minimal metal debris behind the liner noted.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: 1822565 - 2015 - 02219.

Event Description

It was reported patient¿s hip was revised approximately 2 years post implantation due to elevated metal ion levels, metallosis, corrosion, and adverse local tissue response.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: FEMORAL HEAD 12/14 TAPER 32 MM DIAMETER
• 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: 7598719
• MDR Text Key: 110995077
• Report Number: 0002648920-2018-00477
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953337
• 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: 06/13/2018

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: Physician
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801803214
• Device Lot Number: 62484572
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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 Age: 52 YR
• Patient Weight: 60