MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMMER ZIRCONIUM OXIDE CERAMIC HEAD; HIP PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It is reported the pt was revised due to a fractured femoral head; therefore, the head was removed.During the revision, large areas of osteolysis were noted after the shell was removed.

Manufacturer Narrative

Evaluation summary: neither primary nor revision operative notes were returned for review.Attempts have been made to obtain additional info; however, no info has been received to date.An x-ray post-fracture of the femoral head shows a large portion of the femoral head fractured away and is sitting inferior to the cup within the joint.The acetabular shell does not appear to have the appropriate version angle.In general, pt factors that may affect the performance of the components include: age, bone quality, 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 condition is unk, however, a photo of the explanted devices shows a ceramic head fractured in approximately 4 large pieces.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.

• Brand Name: UNK ZIMMMER ZIRCONIUM OXIDE CERAMIC HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4092585
• MDR Text Key: 4745126
• Report Number: 1822565-2014-01066
• 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,Distributor
• 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?: Yes
• 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: LOT# UNK; UNK ZIMMER HARRIS/GALANTE SHELL, CATALOG# UNK,
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR