MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6052-1035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/28/2021
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 usage sheet that the patient's left hip was revised due to periprosthetic fracture.A 36 + 5mm biolox head and #10 secur-fit stem were explanted.Spoke to rep: the fracture occurred on the femur bone, about half way up the length of the stem, but the stem was not fractured.There are no allegations against the revised head.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #10
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12211670
• Report Number: 0002249697-2021-01270
• Device Sequence Number: 17103809
• Product Code: LZO
• UDI-Device Identifier: 07613327021134
• UDI-Public: 07613327021134
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 09/30/2022
• Device Model Number: 6052-1035S
• Device Catalogue Number: 6052-1035S
• Device Lot Number: M84AW0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/22/2021
• 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: 58 YR
• Patient Weight: 57