MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: part: 00801803202, lot: unk; part: unk stem, lot: unk; part: unk cup, lot: unk; part: unk liner, lot: unk.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a left total hip arthroplasty on (b)(6) 2010 due to osteoarthritis.Zimmer biomet products were implanted without complications.The patient was revised on (b)(6) 2017 due to failed hip arthroplasty.Per office notes dated (b)(6) 2017, the patient presented with pain and was limping with pain.Lab reports dated (b)(6) 2017 showed the patient had elevated metal ions in blood - cobalt 10.6 (normal <1.9), chromium 4.0 (normal <3.6), and an x-ray review revealed radiolucency around the acetabular cup and screw.During the revision procedure on (b)(6) 2017, the cup was found to be loose.There was black metallosis around the head and neck.Scar tissue was excised, and the trunnion exhibited trunnionosis.Gluteus medius and minimus were found to be partially torn.Tendons were repaired and the femoral stem was left intact.The femoral head was replaced with a new zimmer biomet product.The cup and liner were replaced with competitor's products.No other findings/complications were noted.Part and lot identification are necessary for review of device history records, neither were provided for the stem, shell and screw.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.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 that patient underwent a revision procedure 17 years post-implantation due to pain and elevated metal ions.During the revision, significant trunnionosis was noted with tears in the gluteus medius and minimus.The acetabular cup was aseptically loose with only fibrous but no bony ingrowth.Black metallosis noted around the head and neck.Gluteus medius and minimus were found to be partially torn.The femoral stem was left intact, all other components were replaced without complication.No further event information available at the time of this report.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5; g3; h2; upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

• Brand Name: BONE SCR 6.5X20 SELF-TAP
• 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: 12084641
• MDR Text Key: 258946957
• Report Number: 0001822565-2021-01778
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• 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: 04/05/2022

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 Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: 61336952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 03/21/2022
• Supplement Dates FDA Received: 11/17/2021; 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White