MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Material Disintegration (1177); Structural Problem (2506)

Patient Problem No Code Available (3191)

Event Date 11/04/2014

Event Type  Injury  

Event Description

The authors report on a dual-center retrieval analysis of the flexural rigidity and length of the femoral trunnions of 85 modular femoral stems.The stems were implanted between 1991 and 2012 and retrieved at revision or removal surgery between 2004 and 2012.There were 10 different taper designs made from five different metal alloys from 16 manufacturers.They found wide variability in flexural rigidity of various taper designs.The three most flexible trunnions all shared the same base alloy (tmzf) and taper geometry (v40).Flexural rigidity is a factor in inducing corrosion because it affects elastic-based micromotion (or fretting) that arises at the modular junction.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown citation tmzf femoral stem.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device not returned to manufacturer.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4289622
• MDR Text Key: 5190781
• Report Number: 0002249697-2014-04454
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2014

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
• Device Catalogue Number: UNK_REC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 12/02/2014
• 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