MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER TM SHELL WITH MULTI HOLES; HIP PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that the pt was revised due to the shell loosening, dislocation and a screw fracture.

Manufacturer Narrative

Info was received via published literature.Eval summary: no devices or photos were received; therefore, the condition of the components is unk.X-ray that was provided shows a dislocated tha.The article noted that the dislocation was due to superior lateral migration of the hip center of rotation, retroacetabular and ischial osteolysis, and screw breakage.Based on the provided info the most likely cause of the dislocation is from the acetabular components migration.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.Zimmer, inc.Considers the investigation closed.

• Brand Name: UNKNOWN ZIMMER TM SHELL WITH MULTI HOLES
• 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: 4553351
• MDR Text Key: 18542862
• Report Number: 1822565-2015-00238
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• 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: 01/23/2015
• 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: UNKNOWN ZIMMER BONE SCREW, CATALOG #UNK, LOT #UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR