MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 36 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Failure of Implant (1924); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products : cat#00875705601, lot# 62616431, continuum cluster-hole.Cat#00771301700, lot#61459936, m/l taper kinectiv stem.Cat#00801803602, lot#62611510, 12/14 cocr femoral head.Cat# 00625006520, lot#77002945, bone screw 6.5x20 selftap.Cat#00625006525, lot#62490927, bone screw 6.5x25 selftap.Cat# 00784802400, lot#62380909, kinectiv modular neck.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip revision approximately 6 years post implantation due to unknown reasons.No additional information.

Event Description

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

Manufacturer Narrative

Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues patient presents with pain, difficulty ambulating, tumor, hip failure with metallosis, tissue damage, solid cup, stem well fixed, no complications.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Upon reassessment of the reported event, the liner was determined to be not reportable.The initial report was forwarded in error and should be voided.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 a left hip revision approximately 6 years post implantation due to pain, ambulation difficulties, elevated metal ions, and pseudotumor formation.During the revision, extensive metallosis and muscular destruction was noted.Heterotopic ossification was removed from the well-fixed shell which was left in place.The well-fixed stem was removed by osteotomy and competitor product placed.No capsular repair could be made due to the soft tissue damage.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a2, b4, b5, b6, b7, d4, d6, g3, h2, h3, h4, h6.

• Brand Name: LINER ELEVATED RIM 36 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: 12467103
• MDR Text Key: 271250926
• Report Number: 0001822565-2021-02601
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• 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,Followup,Followup
• Report Date: 01/18/2022

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: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 00875201236
• Device Lot Number: 62615923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 09/20/2021; 01/11/2022
• Supplement Dates FDA Received: 10/18/2021; 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male