MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY BONE SCR 6.5X30; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Pain (1994)

Event Date 04/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:00771100900 lot number: 61356526 brand name:m / l taper stem, catalog number:00620005222 lot number:61271338 brand name: acetabular shell, catalog number:00625006530 lot number:61432050 brand name: trilogy bone screw, catalog number:00631005032 lot number:61399506 brand name: trilogy liner.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02557, 0002648920-2019-00437, 0002648920-2019-00436.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 reported that the patient was revised due to due to pain, elevated metal ion levels, altr, loosening, and in-vivo corrosion approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

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 underwent a revision procedure due to pain, elevated metal ions, acetabular loosening, corrosion, and altr.Upon entering the wound, fluid under pressure and benign fibrous tissue with mild perivascular lymphocytic infiltrates were observed.There was abundant amorphous eosinophilic fibrinous exudate.The acetabular component had loosened and there was corrosion at the head-neck interface.Pre-operative lab results showed that patient had elevated metal ions - cobalt : 3.7, chromium : 5.5.Post operative lab results showed that the metal ion levels had dropped; cobalt : 0.5, chromium : 0.7.The acetabular components with the bone screw, and the femoral head were removed.New zimmer biomet products were implanted.There are no other findings related to the reported event.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: TRILOGY BONE SCR 6.5X30
• 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: 8707333
• MDR Text Key: 148280928
• Report Number: 0002648920-2019-00438
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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: 02/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 00625006530
• Device Lot Number: 61432050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/29/2019
• 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): Hospitalization; Required Intervention