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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Reaction (2414); Osteopenia/ Osteoporosis (2651)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: zimmer femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 4 extended offset reduced neck length, cat#: 65771100440, lot#: 62289137; zimmer femoral head sterile product do not resterilize 12/14 taper, cat#: 00801803603, lot#: 62346611; zimmer shell porous with cluster holes 50 mm, cat#: 00620205022, lot#62522176; zimmer liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, cat#: 00630505036, lot#: 62452970; zimmer bone scr 6.5x35 self-tap, cat#: 00625006535, lot#: 62417713.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00360.

Event Description

It was reported the patient underwent left hip revision approximately 5 years post initial implantation due to elevated cobalt levels.It was noted the cocr head was removed and replaced with a biolox head.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records provided.Review of the records demonstrated the following: the patient underwent a revision due to metallosis, altr, pseudotumor, tissue damage, and implant wear.Imaging taken revealed osteopenia.Blood testing revealed elevated cobalt levels.Revision operative notes revealed metallosis and altr with indications of chronic tearing of external rotators.The femoral component was well fixed and well positioned.Trunnion was found slightly burnished.A large pseudocyst seal was found posteriorly.Xrays were provided however they were not sent for review as the provided medical records were sufficient and the xrays would not enhance the investigation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

Event Description

It was reported the patient underwent left hip revision approximately 5 years post initial implantation due to elevated cobalt levels, metallosis, altr, pseudotumor, tissue damage, and wear.The head and liner were removed and replaced.No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10351979
• MDR Text Key: 201608826
• Report Number: 0001822565-2020-02733
• Device Sequence Number: 1
• Product Code: MEH
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 65771100440
• Device Lot Number: 62289137
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other