MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER M/L TAPER STEM; HIP PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Unspecified Infection (1930)

Event Date 05/20/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: primary operative notes were received and were unremarkable.Revision operative notes stated a possible infection with observation of a loose femoral stem.Undated x-rays were provided which show well placed components.There may be a faint radiolucent line appearing around the femoral stem between two separate films, however, the time frame of the films are unknown.In general, patient factors that may affect the performance of the components include: age, bone quality, height/weight, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto is unknown.Cause cannot be definitively determined.Evaluation: review of the device history records was not possible as the product and lot numbers required for retrieval were unavailable.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

Event Description

It is reported, the patient underwent a two-stage revision for infection and loosening.The first stage occurred on (b)(6) 2014 and the second stage occurred on an unknown date.

• Brand Name: UNKNOWN ZIMMER M/L TAPER STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3975712
• MDR Text Key: 21167862
• Report Number: 1822565-2014-00823
• Device Sequence Number: 1
• Product Code: LPH
• 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,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2014

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: 06/10/2014
• Initial Date FDA Received: 07/09/2014
• 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: UNKNOWN TRILOGY SHELL WITH CLUSTER HOLES,; CATALOG# UNK, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR