MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK; IMPLANT

Catalog Number 6565-0-136

Device Problems Break (1069); Collapse (1099); Fracture (1260); Human-Device Interface Problem (2949); Material Integrity Problem (2978)

Patient Problems Crushing Injury (1797); No Code Available (3191)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Event Description

The sales rep has reported on behalf of the customer that a patient has had to undergo revision surgery on an alumina ceramic head (36), an exeter stem and a liner due to an industrial sized oil tank falling on the patient and crushing the alumina head.The sales rep has reported that the shell did not need to be revised.The sales rep has reported that due to the state of the alumina head, it cannot be returned for further investigation.The original devices were implanted in 2011.Update july 30, 2015: the customer has reported that they had to replace the acetabular insert, the femoral head and exchange the stem for an in-cement revision short stem as there was considerable damage to the trunion on the stem.Revision surgery date was (b)(6) 2015.

Manufacturer Narrative

It was reported that a patient underwent revision surgery on an alumina ceramic head as a result of a trauma which resulted in the fracture alumina head.This was confirmed from the photographic images provided.The device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated there has been one similar event for the reported lot.

Event Description

The sales rep has reported on behalf of the customer that a patient has had to undergo revision surgery on an alumina ceramic head (36), an exeter stem and a liner due to an industrial sized oil tank falling on the patient and crushing the alumina head.The sales rep has reported that the shell did not need to be revised.The sales rep has reported that due to the state of the alumina head, it cannot be returned for further investigation.The original devices were implanted in 2011.Update july 30, 2015: the customer has reported that they had to replace the acetabular insert, the femoral head and exchange the stem for an in-cement revision short stem as there was considerable damage to the trunnion on the stem.Revision surgery date was (b)(6) 2015.

• Brand Name: ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5027357
• MDR Text Key: 23932831
• Report Number: 0002249697-2015-02764
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 6565-0-136
• Device Lot Number: 36854403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2011
• 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