MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 15 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-7-015
Medical Device Problem Codes	Crack (1135); Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.Conclusion: review of these records confirms failure of the femoral component of a restoration modular femoral stem necessitating revision surgery.The root cause cannot be determined as insufficient information was available.It should be noted however, that he patients right hip had multiple previous operations including revision tha.During the revision of 2014 a trochanteric plate with cables was placed on the proximal femur.The reason for the fixation device is likely to be fracture or controlled proximal femoral osteotomy either of which could compromise proximal fixation of the femoral component.Assuming the stem was still well fixed distally the stress concentrate at the junction of fixed/nonfixed and repetitive load could lead to stem failure.
Event or Problem Description
Failed revision total hip.Patient was being watched for loose stem by surgeon and was planning on revision upon retirement.Due to stem failure revision was necessary at this time by a different surgeon.

• Brand Name: MOD CON DIST STEM 15 X 155 MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7602934
• Report Number: 0002249697-2018-01815
• Device Sequence Number: 19238475
• Product Code: LPH
• UDI-Device Identifier: 04546540643735
• UDI-Public: 04546540643735
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 6276-7-015
• Device Lot Number: CAXR30XC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR