MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-1-019
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
As reported: "patient presented with pain of the left hip.X-rays demonstrated a fractured femoral component (perioperative management report states "fracture of the femoral stem at the modular junction").Patient was revised to another femoral component from a different manufacturer.The acetabular component was retained." a restoration modular stem construct and 40 +0 v40 head were revised.
Additional Manufacturer Narrative
An event regarding crack/fracture involving restoration modular cone body was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray image confirms fractured stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.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: medical review has confirmed the reported stem fracture however the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are needed to fully investigate the event.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "patient presented with pain of the left hip.X-rays demonstrated a fractured femoral component (perioperative management report states "fracture of the femoral stem at the modular junction").Patient was revised to another femoral component from a different manufacturer.The acetabular component was retained." a restoration modular stem construct and 40 +0 v40 head were revised.

• Brand Name: 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019
• 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: 9530706
• Report Number: 0002249697-2019-04127
• Device Sequence Number: 14047221
• Product Code: LPH
• UDI-Device Identifier: 04546540641069
• UDI-Public: 04546540641069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/24/2020

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: 12/31/2020
• Device Model Number: 6276-1-019
• Device Catalogue Number: 6276-1-019
• Device Lot Number: 53696503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 02/24/2020
• 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: 64 YR
• Patient Weight: 117