MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY SECUR-FIT PLUS MAX #7/11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6054-0711S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Date of Event	07/30/2018
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 reported lot.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's right hip was revised after patient complaint of limb length discrepancy and pain.X-ray revealed that stem had subsided.It was discovered that subsidence occurred progressively after patient suffered an unreported periprosthetic fracture that the patient decided to let go untreated.Patient had a reported bmi of 39.The liner and head were exchanged for larger-sized stryker devices.The stem and shell remained in the patient.
Additional Manufacturer Narrative
An event regarding subsidence involving a securfit stem following a periprosthetic fracture was reported.The event was confirmed through clinician review of the provided x-rays.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.The stem remains implanted.-clinician review: the provided medical records were rejected by a clinical consultant who indicated: "x-ray confirms subsidence of the stem, need operative reports, need patient clinical notes, no confirmation of post op revision treatments, need serial x-rays and examination of the explanted components".-product history review: indicated 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 lot referenced.Conclusions: the provided medical records were rejected by a clinical consultant who indicated: x-ray confirms subsidence of the stem.Further information such as operative reports, patient clinical notes, confirmation of post op revision treatments, serial x-rays and examination of the explanted components are required to complete the investigation for determining a root cause.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
It was reported that patient's right hip was revised after patient complaint of limb length discrepancy and pain.X-ray revealed that stem had subsided.It was discovered that subsidence occurred progressively after patient suffered an unreported periprosthetic fracture that the patient decided to let go untreated.Patient had a reported bmi of 39.The liner and head were exchanged for larger-sized stryker devices.The stem and shell remained in the patient.

• Brand Name: PRIMARY SECUR-FIT PLUS MAX #7/11
• 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: 7818689
• Report Number: 0002249697-2018-02675
• Device Sequence Number: 2447190
• Product Code: LZO
• UDI-Device Identifier: 07613327020847
• UDI-Public: 07613327020847
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/03/2018

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: 09/30/2021
• Device Catalogue Number: 6054-0711S
• Device Lot Number: 8N7LHN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 54 YR
• Patient Weight: 95