MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 SUMMIT BASIC PRESS FIT SZ 3; HIP FEMORAL STEM/SLEEVE

Catalog Number 157005090

Device Problems Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 01/14/2015

Event Type  Injury  

Manufacturer Narrative

The complaint states patient was revised due to a loose press fit stem.The stem was undersized and needed to be removed.A review of complaints database and manufacturing records did not identify any anomalies.No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.The complaint shall be closed with an undetermined conclusion; it will be entered into the complaint database and monitored through trend analysis.

Event Description

Patient was revised due to a loose press fit stem.The stem was undersized and needed to be removed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Brand Name: SUMMIT BASIC PRESS FIT SZ 3
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 2151 2-6; CH 21512-6
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou 2151 2-6; CH 21512-6
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4481187
• MDR Text Key: 19862087
• Report Number: 1818910-2015-12512
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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
• Device Expiration Date: 05/06/2015
• Device Catalogue Number: 157005090
• Device Lot Number: D10041034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2010
• 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: 70 YR