MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMER FEMORAL HEAD; HIP PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

It is reported the pt was revised due to a mass over the anterior aspect of the left hip.During the revision, a large sac containing blackish brown debris around the proximal femur was found.The debris was removed and the sac excised.It was also found that the locking mechanism had failed and the poly liner was spinning in the metal shell.Bone scan results suggest osteolysis and loosening of the shell and stem.

Manufacturer Narrative

Info was received via published literature.Evaluation summary: neither operative notes nor x-rays were returned for review.Attempts have been made to obtain additional info; however, no info has been received to date.In general, pt factors that may affect the performance of the components include: age, bone qual, height/weight, activity level, type of activity, and relevant med history.Rehabilitation protocol and adherence thereto is unk.Cause cannot be definitively determined.Evaluation codes: no devices were returned for review, so their exact conditions are unk.Review of the device history records was not possible as the product and lot numbers required for retrieval were unavailable.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available info, the need for corrective action is not indicated.Should additional substantive info be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

• Brand Name: UNK ZIMMER FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4092584
• MDR Text Key: 4831681
• Report Number: 1822565-2014-01069
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK ZIMMER TRILOGY SHELL, CAT #UNK, LOT #UNK; UNK ZIMMER FEMORAL STEM, CAT #UNK, LOT #UNK; UNK ZIMMER POLY LINER, CAT #UNK, LOT #UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR