MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY SUPER SECUR-FIT PLUS SIZE 10-14MM DISTAL STEM DIA.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	J6054-1014
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received will be provided in a supplemental report.Not returned.
Event or Problem Description
After implementing tha on (b)(6) 2003, confirmed breaking at the stem distal slit section on x - ray in around 8 years.No change is seen in patient's activity based on x - ray findings.
Event or Problem Description
After implementing tha on (b)(6)2003, confirmed breaking at the stem distal slit section on x - ray in around 8 years.No change is seen in patient's activity based on x - ray findings.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a securefit stem was reported.The event was confirmed.Confirmed: through review of the provided medical records and x-rays by a clinical consultant.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms failure of the tha femoral component due to fracture within the fluted portion of the stem occurred.The root cause cannot be determined as insufficient information was available.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the event was confirmed through review of the provided medical records and x-rays by a clinical consultant, however the root cause could not be determined because insufficient information was provided.Additional information, including operative reports, product id, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: PRIMARY SUPER SECUR-FIT PLUS SIZE 10-14MM DISTAL STEM DIA.
• 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: 7616522
• Report Number: 0002249697-2018-01886
• Device Sequence Number: 11311570
• Product Code: LPH
• UDI-Device Identifier: 04546540003164
• UDI-Public: 04546540003164
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: J6054-1014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/01/2018
• 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: Other; Required Intervention