MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #7; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number	6052-0730S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	12/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Patient had a primary total hip (b)(6) 2018.She fell in rehab and fractured her femur.She was taken to the operating room and revised to a cone conical with a dall miles trochanteric plate and cables.Operation was completed successfully.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a securfit stem was reported.The event was confirmed by the medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "on (b)(6) 2018 she underwent a primary right total hip arthroplasty for which no operative report is available.On (b)(6) 2018 she underwent a revision right total hip arthroplasty and an open reduction/internal fixation of a periprosthetic fracture of the right femur.No operative report is available for this.Implant labels indicate a dall-miles medium 200ml trochanteric grip plate with two cables, along with six additional dall-miles beaded cable sets and sleeves, a 155/17 restoration modular hip stem, a 19/0 v-40 restoration proximal body, and a 36/minus-5 v-40 biolox head were utilized.An x-ray printout dated (b)(6) 2018 is an ap of the right hip demonstrating a comminuted fracture of the proximal femur with a dislocated uncemented total hip arthroplasty with stem subsidence and two screws noted in the acetabulum.An x-ray dated (b)(6) 2018 is an ap of the pelvis, portable, demonstrating a right uncemented total hip arthroplasty with the same acetabular component, but a long-stem modular femoral component and a lateral trochanteric grip plate fixed with eight cerclage cables.The fracture is anatomically reduced, the hip is reduced, and the components appear in nominal position.No clinical or past medical history, no operative reports and no examination of explanted components are available.There is no evidence this traumatic periprosthetic fracture was related to factors of faulty implant design, manufacturing or materials.In retrospect, a primary cemented femoral component may have avoided this traumatic event." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that patient was revised due to periprosthetic fracture.A review of the provided medical records and/or x-rays by a clinical consultant indicated that an x-ray printout dated (b)(6) 2018 is an ap of the right hip demonstrating a comminuted fracture of the proximal femur with a dislocated uncemented total hip arthroplasty with stem subsidence and two screws noted in the acetabulum.No clinical or past medical history, no operative reports and no examination of explanted components are available.There is no evidence this traumatic periprosthetic fracture was related to factors of faulty implant design, manufacturing or materials.In retrospect, a primary cemented femoral component may have avoided this traumatic event.The exact cause of the event could not be determined because insufficient information was provided.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 (b)(6) 2018.She fell in rehab and fractured her femur.She was taken to the or and revised to a cone conical with a dall miles trochanteric plate and cables.Operation was completed successfully.As per medical review: ".Comminuted fracture of the proximal femur with a dislocated uncemented total hip arthroplasty with stem subsidence.".

• Brand Name: SECUR-FIT MAX 127 HIP STEM #7
• Common Device Name: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8217974
• Report Number: 0002249697-2019-00046
• Device Sequence Number: 13511432
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 04/30/2023
• Device Catalogue Number: 6052-0730S
• Device Lot Number: LV23NM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2018
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: 82 YR
• Patient Weight: 49