MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Blood Loss (2597)

Event Date 03/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:00620205422, lot number:62601628, brand name: tm modular cup; catalog number:00625006530, lot number:62619020, brand name: bone screw; catalog number:00625006520 ,lot number: 62622405, brand name: bone screw; catalog number: 00625006520, lot number:62619022, brand name: bone screw; catalog number: 00631005032, lot number:62595137, brand name: xlpe liners; catalog number: 00771100900, lot number:61356526, brand name: m/l taper stem; catalog number: 00877703202, lot number:2702048, brand name: biolox head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02553, 0002648920-2019-00433, 0002648920-2019-00434.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reports that the patient was revised due to loosening of the acetabular cup approximately 1 year post implantation.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient was revised due to grossly loose acetabular components and scar-like changes on the trunnion.Upon entering the fascia, there was a large collection of fluid that was clear and looked like a synovial fluid.No greyness was evident to suggest some sort of metal issue based on the fluid alone.Large psuedocapsule present that was thick likely from the first revision.Trunnion was noted to have a fair amount of scarring.Not much in the way of corrosive changes or the black changes that are common with frank metallosis.No grossly evident corrosive changes in the femoral head.Synovitis was removed.The acetabular cup had migrated and overall version was well into the 60s.The cup was easily removed.There was some posterior-superior defect.Due to the loosening of the cup, there was a fairly-large acetabulum.Periprosthetic heterotopic ossification and osteophytic change at the greater trochanter appear unchanged.Blood loss of 1000cc is noted during the revision.Reported event was confirmed by review of medical records provided.Device history record 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.

Event Description

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

• Brand Name: BONE SCR 6.5X20 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8707044
• MDR Text Key: 148268583
• Report Number: 0002648920-2019-00435
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: 62619022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• 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