MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6052-0730S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Product not returned.
Event or Problem Description
Patient had a primary total hip.She did well until she fell.She was seen in the er and x-rays were taken.She sustained a periprosthetic fracture.She was taken to the operating room and revised.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a securfit stem was reported.The event was confirmed through clinician review of the medical records provided.Method & results: -product evaluation and results: the reported device was not returned however one photograph was provided for review.The photographs provided are of the recently explanted stem and head.Blood is visible on both the head and stem.Small fragments of tissue is also visible on the body of the stem.-clinician review: a review of the provided medical records by a clinical consultant indicated: a traumatic fall of this 80-year old female patient with osteoporosis some 3-years post arthroplasty has caused a complex periprosthetic fracture around the securefit max stem with consequent stem loosening requiring revision surgery with fracture stabilization and implantation of a longer revision stem construct.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding periprosthetic fracture was reported.Review of the provided medical records by a clinical consultant indicated: a traumatic fall of this 80-year old female patient with osteoporosis some 3-years post arthroplasty has caused a complex periprosthetic fracture around the securefit max stem with consequent stem loosening requiring revision surgery with fracture stabilization and implantation of a longer revision stem construct.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a primary total hip.She did well until she fell.She was seen in the er and x-rays were taken.She sustained a periprosthetic fracture.She was taken to the or and revised.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #7
• 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: 8130282
• Report Number: 0002249697-2018-03893
• Device Sequence Number: 1653207
• Product Code: LZO
• UDI-Device Identifier: 07613327021103
• UDI-Public: 07613327021103
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 12/31/2019
• Device Catalogue Number: 6052-0730S
• Device Lot Number: MNNL7X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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: 80 YR
• Patient Weight: 41