MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 6051-0935S

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

Reported event an event regarding fretting, corrosion and abnormal ion level involving a securfit stem was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lift c-taper femoral head on his right hip on or about (b)(6) 2013 and was revised on (b)(6) 2018.It is further alleged that he began experiencing significant pain in his hip in 2018, mri demonstrated "very large joint infusion with progressive osteolytic changes" and "laboratory results showed elevated cobalt levels in his blood as 17.7 mcg/l and his chromium as 3.5 mcg/l".It is alleged that during the revision surgery on (b)(6) 2018 the surgeon noted signs of fretting and corrosion at the neck and revised the acetabular liner and the femoral head.

• Brand Name: SECUR-FIT MAX 132 HIP STEM #9
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11854015
• MDR Text Key: 255209550
• Report Number: 0002249697-2021-00886
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07613327021035
• UDI-Public: 07613327021035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 6051-0935S
• Device Catalogue Number: 6051-0935S
• Device Lot Number: MMJ4EM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2013
• 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