MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 9 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1601-09127
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/11/2019
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 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.Device not returned.
Event or Problem Description
Patient was seen by another surgeon and had a reoperation on her left hip (study device side).Surgeon performed a hip arthroscopy with lysis of adhesions, trochanteric bursectomy, iliotibial band release, and prp injection to the abductor tendon.The study device was not revised.Patient has had ongoing bursitis and reported pain since (b)(6) 2018.Dr.Does not believe the study device is the cause of the reoperation.

• Brand Name: 127 SIZE 9 SECUR-FIT ADVANCED STEM
• 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: 9734815
• Report Number: 0002249697-2020-00367
• Device Sequence Number: 13541426
• Product Code: LPH
• UDI-Device Identifier: 07613327021332
• UDI-Public: 07613327021332
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 02/28/2019
• Device Model Number: 1601-09127
• Device Catalogue Number: 1601-09127
• Device Lot Number: MMTW45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/20/2020
• 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: 67 YR
• Patient Weight: 87