MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABC ALUMINA CERAMIC INSERT; IMPLANT

Catalog Number 2047-2848

Device Problem Metal Shedding Debris (1804)

Patient Problem Toxicity (2333)

Event Date 03/11/2015

Event Type  Injury  

Event Description

Patient's left hip was revised due to metallosis and ceramic debris.(b)(6) study patient.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

An event regarding crack/fracture involving an abg liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: not performed as medical records were not provided.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as returned of the device, x-rays, operative reports as well as patient history and follow-up notes are needed to further investigate this event.No further investigation is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Patient's left hip was revised due to metallosis and ceramic debris.(b)(4) study patient.

• Brand Name: ABC ALUMINA CERAMIC INSERT
• 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: 4665332
• MDR Text Key: 5625779
• Report Number: 0002249697-2015-01080
• Device Sequence Number: 1
• Product Code: MRA
• 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,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2002
• Device Catalogue Number: 2047-2848
• Device Lot Number: 152655061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• 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
• Patient Age: 76 YR
• Patient Weight: 79