MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 4 LEFT NEUT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	4845-7-214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.Device evaluated by manufacturer? not returned.
Event or Problem Description
This pi is for the revised implants of the left hip.It was reported that the patient suffered bilateral femoral fractures 6 days after having a bilateral hip replacement.The anato stems and biolox heads were revised to restoration modular stem constructs and biolox heads.

• Brand Name: ANATO STEM SZ 4 LEFT NEUT
• 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: 8758220
• Report Number: 0002249697-2019-02524
• Device Sequence Number: 1489500
• Product Code: LPH
• UDI-Device Identifier: 07613252631316
• UDI-Public: 07613252631316
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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: 08/31/2023
• Device Catalogue Number: 4845-7-214
• Device Lot Number: 65612805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/03/2019
• 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: 69 YR