MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BOWED CONICAL STEM 14 X 195MM RESTORATION MODULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/04/2020
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
A restoration modular stem was revised due to suspected non union of previous periprosthetic fractures.
Additional Manufacturer Narrative
Reported event an event regarding periprosthetic fracture involving a restoration modular stem was reported.A medical review of the provided x-ray confirmed the event.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: rejected for medical review {.]: " re pi - 2343901 which represents a 75 y/o female patient described as 160 cm tall and weighing 67 kg who underwent an explantation on (b)(6) 2020.The event description states:"restoration modular stem revised due to suspected non-union of previous periprosthetic fracture left side." implant labels dated 9/25/19: restoration modular long stem195/14, 23/0 v-40 body, 36/0 v-40 lfit head, 3 cable sets, 1 screw.X-ray dated (b)(6) 2020 ap left hip rest.Mod.Long stem tha reduced, long lateral femoral plate fixed with 4 intact screws proximally, 3 cables, 2 broken screws, and a femoral non-union oblique fracture of the femur 6 cm distal to lesser trochanter.O clinical or pmh, no operative reports, no serial images, no examination of explanted components.Base upon the information available for review, confirmation of the event description is possible, but insufficient data to create a medical report on this case.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A restoration modular stem was revised due to suspected non union of previous periprosthetic fractures.

• Brand Name: BOWED CONICAL STEM 14 X 195MM RESTORATION MODULAR HIP SYSTEM
• 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: 9904216
• Report Number: 0002249697-2020-00650
• Device Sequence Number: 690160
• Product Code: LPH
• UDI-Device Identifier: 07613154058754
• UDI-Public: 07613154058754
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 07/31/2023
• Device Model Number: 6276-7-214
• Device Catalogue Number: 6276-7-214
• Device Lot Number: CAXWD1TH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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: 75 YR
• Patient Weight: 67