MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER SHELL; HIP PROSTHESIS

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It is reported that the pt was revised due to pain and pullout of the cup.

Manufacturer Narrative

Info was received via published literature.Evaluation summary: the pt has previous history of revisions for aseptic loosening, instability, and pelvis disassociation.Surgical notes were not provided.X-rays were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Attempts have been made to obtain additional info however no info has been received to date.Pt factors that may affect the performance of the components such as bone quality, height/weight, type of activity (low impact vs high impact), and relevant medical history are unk.Adherence to rehabilitation protocol is unk.A definitive root cause cannot be determined with the info provided.Evaluation codes: review of the device history records was not possible as the product and/or 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.

• Brand Name: UNKNOWN ZIMMER SHELL
• 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: 4134931
• MDR Text Key: 4942945
• Report Number: 1822565-2014-01255
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/29/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/25/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR