MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 8 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	1601-08127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced.
Event or Problem Description
It was reported that when implanting a stem in a primary right hip procedure, the patient's femur fractured.Surgeon used a cable to address the fracture and retained the femoral stem.

• Brand Name: 127 SIZE 8 SECUR-FIT ADVANCED STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11161928
• Report Number: 0002249697-2021-00108
• Device Sequence Number: 3719440
• Product Code: JDI
• UDI-Device Identifier: 07613327021318
• UDI-Public: 07613327021318
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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 Expiration Date: 07/31/2025
• Device Model Number: 1601-08127
• Device Catalogue Number: 1601-08127
• Device Lot Number: L879Y9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2020
• Initial Report FDA Received Date: 01/13/2021
• 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: 62 YR
• Patient Weight: 118