MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.; PROSTHESIS , HIP

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem Host-Tissue Reaction (1297)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:65771100920, lot number: 60707596, brand name: m/l taper stem.Catalog number:00801803202, lot number:61047644, brand name: trilogy cups.Catalog number:00630505032, lot number: 61034302, brand name: xlpe liner.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00488.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 metallosis and pseudotumor.Patient had elevated metal ions and mri imaging demonstrated large fluid collection.There was tissue destruction inside of the hip secondary to pseudotumor.The trochanter was bald with no abductor muscles attached anymore.There was corrosion on the trunnion and taper of the femoral head.The locking ring was bent and the new locking ring did not engage properly.The shell, liner, and head were removed.The patient tolerated the procedure well.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

It was reported that the patient was revised due to metallosis approximately 8 years post implantation.During the revision, the locking ring was bent and the new locking ring did not engage properly.The shell, liner, and head were removed.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8747944
• MDR Text Key: 149638386
• Report Number: 0002648920-2019-00489
• Device Sequence Number: 1
• Product Code: LPH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2018
• Device Model Number: N/A
• Device Catalogue Number: 00620005422
• Device Lot Number: 61050724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2008
• 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
• Patient Age: 70 YR