MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0737
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/04/2021
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported through the submission of a revision implant sheet that the patient's left hip was revised.Spoke to the branch operations manager, who said that the rep had reported that the patient was revised due to a femoral periprosthetic fracture sustained in a fall.Rep had also reported there were no allegations against the stryker implants.An accolade ii stem and biolox head were revised to a restoration modular stem construct with another ceramic head, and 2 cable and sleeve sets.Update 06/august/2021 wg: additional information provide by the rep: "reported to hospital for revision surgery.I was told that the patient fell the day before at grocery store.Bone broke around stem that was placed on (b)(6) 2021 causing it to be loose.We removed the stem and femoral.Cerclaged the bone and placed a revision stem and new femoral head.No negative product experience reported by surgeon.No implants, no xrays, no information returned per policy of hospital.".

• Brand Name: SIZE 7 ACCOLADE II 132 DEG
• 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: 12365045
• Report Number: 0002249697-2021-01461
• Device Sequence Number: 11734324
• Product Code: LPH
• UDI-Device Identifier: 04546540664501
• UDI-Public: 04546540664501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 01/31/2026
• Device Model Number: 6720-0737
• Device Catalogue Number: 6720-0737
• Device Lot Number: 81360902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: 40 YR