MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 50 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Synovitis (2094); Osteolysis (2377)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803602 ¿ cocr femoral head ¿ 61555324, 00784800200 ¿ m/l taper g2 neck ¿ 61510849, 00630505036 ¿ xlpe liner - 61515708, 00771300600 ¿ m/l taper stem ¿ 60862140.Reported event was confirmed by review of operative notes stating that corrosion was found around the head and neck junction and synovitis was debrided.Lab records also show patient had elevated metal ion levels preoperatively.Review of radiographs show radiolucency along the acetabular cup and proximal femoral component consistent with osteolysis.Dhr was reviewed and no discrepancies 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: 0002648920 - 2018 - 00875, 0001822565 - 2018 - 07013, 0001822565 - 2019 - 03226.

Event Description

It was reported patient underwent a left hip revision approximately 8 years post implantation due to pain, swelling, elevated metal ion levels.X-rays taken note radiolucency around the cup and stem during the procedure, yellow tinged fluid was extracted from the joint, and synovitis was debrided.There was a small ring of corrosion around the femoral head and neck junction and the liner was found to be jammed within the cup.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 50 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8842637
• MDR Text Key: 152685257
• Report Number: 0001822565-2019-03225
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00620205022
• Device Lot Number: 61465185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2010
• 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: 69 YR
• Patient Weight: 78