MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 10 DEGREE ELEVATED RIM 32 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Discolored (1170); Scratched Material (3020)

Patient Problems Host-Tissue Reaction (1297); Debris, Bone Shedding (1803); Pain (1994); Tissue Damage (2104)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00620005420, lot number: 61260606, brand name: acetabular shell; catalog number: 00625006540, lot number: 60897278, brand name: bone screw; catalog number: 00625006520, lot number: 61070811, brand name: bone screw; catalog number:00625006525, lot number: 61319981, brand name: bone screw; catalog number: 00801803202, lot number: 61111779, brand name: cocr head; catalog number: 00784101250, lot number:60121561, brand name: versys stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-02374, 0002648920-2019-00503, 0002648920-2019-00504.The patient underwent a revision procedure due to failed right total hip arthroplasty secondary to metallosis and trunnionosis.Patient had elevated metal ions with cobal level around 3 and chromium level about 1.1.A pseudocapsule with dark serosanguineous fluid was observed.The hip was very stiff.There was soft tissue damage with necrosis in the synovium, and bone loss in the posterolateral regions of acetabulum.There was some wear on the trunnion with a small black rim of debris at the base of trunnion indicating corrosion.The liner was discolored and exhibited wear.The head and liner were removed.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.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to metallosis and trunnionosis approximately 7 years post implantation.During the revision, a pseudocapsule with dark serosanguineous fluid was observed and bone loss in the posterolateral regions of acetabulum.The liner was discolored and exhibited wear.Additional information on the reported event is unavailable.

• Brand Name: LINER 10 DEGREE ELEVATED RIM 32 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: 8768837
• MDR Text Key: 150304707
• Report Number: 0001822565-2019-02808
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 00631005032
• Device Lot Number: 60988342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention