MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BOWED CONICAL STEM 16 X 195MM RESTORATION MODULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-7-216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/06/2019
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.
Event or Problem Description
It was reported that the patient's right hip was revised due to the distal portion of the distal stem breaking inside the patient's femur.No possible cause or contributor was reported to the rep.Patient's restoration modular stem and a femoral head were revised to competitor devices.Rep provided pre-revision x-rays and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a restoration modular stem was reported.The event was confirmed by provided photograph and the clinician review.Method & results -product evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph notes a recently explanted stem with blood and tissue on it.It fractured at distal tip end.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "x-rays confirms fractured stem, need operative reports, clinical and past medical history." -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 clinician review confirmed the stem fracture but it requires operative reports, clinical and past medical history to conduct a detailed medical review.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, clinical and past medical history as well as further evaluation of the device 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
It was reported that the patient's right hip was revised due to the distal portion of the distal stem breaking inside the patient's femur.No possible cause or contributor was reported to the rep.Patient's restoration modular stem and a femoral head were revised to competitor devices.Rep provided pre-revision x-rays and reported that no further information will be available.

• Brand Name: BOWED CONICAL STEM 16 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: 8658102
• Report Number: 0002249697-2019-02131
• Device Sequence Number: 2247483
• Product Code: LPH
• UDI-Device Identifier: 07613154058778
• UDI-Public: 07613154058778
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: 05/31/2011
• Device Catalogue Number: 6276-7-216
• Device Lot Number: CAXG406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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: 51 YR
• Patient Weight: 110