MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Synovitis (2094); Osteolysis (2377); No Code Available (3191)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age or date of birth: unknown day in (b)(6).Concomitant medical products: catalog#: 00877704404 bioloxâ® option, head, xl, 㸠44/+7, taper 12/14 lot#: 2692724.Catalog#: 0100551310 fitmoreâ®, hip stem, uncemented, offset b (extended)/10, taper 12/14 lot#: 2649759.Report source: foreign: (b)(4).The device will not be returned for analysis as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that at the patient's 7 year post implantation visit, it was noted that the patient had supraacetabular cavity osteolysis.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that at the patient's 7 year post implantation visit, it was noted that the patient had supraacetabular cavity osteolysis and radiolucency.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

The event was confirmed with medical records received.Review of the available records identified: the patient underwent a left tha due to oa; no intraoperative complications were noted.The acetabular inclination and anteversion angles were measured at 34 degrees and 16 degrees respectively.During the patient's seven year post op visit, supraacetabular cavity osteolysis was confirmed by ct.The patient is completely asymptomatic and satisfied with the result of the surgery.The acetabular inclination and anteversion angles remain unchanged.Periprosthetic radiolucency affecting the femoral and acetabular component in relation to prosthetic mobilization.Osteolysis area of 47x25 mm in acetabular wall.No joint effusion.Mri results identified: periprosthetic osteolysis; findings are compatible with granulomatous reaction/fluid reactive synovitis.Dhr was reviewed and no discrepancies relevant to the reported event 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: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 54 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11035583
• MDR Text Key: 222271098
• Report Number: 0001822565-2020-04149
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00151505444
• Device Lot Number: 62227925
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Weight: 95