MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT

Catalog Number 6260-9-236

Device Problem Material Erosion (1214)

Patient Problem No Code Available (3191)

Event Date 10/13/2014

Event Type  Injury  

Event Description

It was reported that patient had a right hip revision because the neck of the stem was eroded.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown head.It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

(b)(6).An event regarding wear involving an accolade stem was reported.Conclusion: no allegation of failure was made against the device.Based on the information provided there is no indication that the product reported in this investigation contributed to the event.

Event Description

It was reported that patient had a right hip revision because the neck of the stem was eroded.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4221812
• MDR Text Key: 4969259
• Report Number: 0002249697-2014-04161
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• 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,Followup
• Report Date: 10/13/2014

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 Expiration Date: 04/30/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: UNKNOWN
• Other Device ID Number: STERILE LOT: MSHEH03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 86