MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER G2 MODULAR NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: modular neck k 12/14 neck taper, use with +0 heads only, cat#: 00784800200, lot#: 62002534.Femoral head sterile product, do not resterilize 12/14 taper, cat#: 00801803602, lot#: 62122119.Modular femoral stem press-fit plasma sprayed cementless size 9, cat#: 00771300900, lot#: 62059087.Bone scr 6.5x35 self-tap, cat#: 00625006535, lot#: 62090579.Bone scr 6.5x35 self-tap, cat#: 00625006535, lot#: 62073994.Liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells.Cat#: 00630505036, lot#: 62092168.Shell porous with cluster holes 54 mm, cat#: 00620205422, lot#: 62085877.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00815, 0001822565-2019-04768.

Event Description

It was reported that a patient underwent an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 7 years later due to pain, elevated metal ions, and a stress reaction of the right femur.During the revision, it was noted that there was slight corrosion at the head/neck junction, but no surrounding devitalization of surrounding tissue was found.It was further noted, the sciatic nerve was encased in scar tissue and it was not thoroughly dissected out.The head and liner were replaced.The surgeon then performed an open reduction internal fixation by applying bmp and three cables around the femoral shaft for fixation.Finally, while testing the fixation of the acetabular shell, the surgeon attempted to remove the fixation screws.The first screw was removed easily, but the second screw appeared to be cold welded to the shell and stripped while trying to remove it.The stripped screw was left in place, and the first screw was replaced without further complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed with medical records provided.Review of the available records identified the following: during a follow up visit patient was diagnosed with pain and elevated levels of cobalt (7.5) and chromium(6.4) were noted.Revision was performed.During revision stress reaction of femur and slight corrosion at the head/neck junction were noted.Orif was performed on the femoral shaft with cerclage cables to hold the fragments.The stem and shell were well-fixed.One of the screws cold-welded to the shell, stripped during removal and was left in the patient.Review of x-rays identified that the components were anatomically aligned.There was no fracture or dislocation or osteolysis identified.Extensive stress reaction along the proximal femoral shaft was observed.Review of the device history records identified no deviations or anomalies during manufacturing.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

No further event information available at the time of this report.

• Brand Name: M/L TAPER G2 MODULAR NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9314696
• MDR Text Key: 170493880
• Report Number: 0001822565-2019-04767
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 00784800200
• Device Lot Number: 62002534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2020
• 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: 77