MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II TMZF HA #8X 37 MM X 127 FEMORAL STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient fell down and with a total hip, patient has a periprosthetic fracture.Doctor revise it to a revision stem and femoral head and left the original cup and liner in.

Manufacturer Narrative

An event regarding a periprosthetic fracture involving an unknown accolade stem was reported.The event was confirmed following a review by a clinical consultant.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review by a clinical consultant noted: the type of fracture was apparently such that the fixation section of the stem was involved and consequently the stem had turned loose requiring revision.Frequently fracture stabilisation is required with dall-miles cables/plate types of systems about which there is also no info for this patient.The cup was left in place.Its mechanical stability was apparently adequate although no further surgical details were provided about the revision procedure other than that the stem was revised with a new femoral head implanted.A traumatic fall of a patient is not a normal condition but a patient-related adverse event causing acute overload in the bone surrounding the device and this represents the root cause of failure by pp-fracture in this pi case.Conclusions: a review by a clinical consultant concluded:a traumatic fall of the patient at 1½-years post arthroplasty caused a periprosthetic fracture requiring revision with stem exchange.Further information such as device details, return of device, revision surgery operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Patient fell down and with a total hip, patient has a periprosthetic fracture.Doctor revise it to a revision stem and femoral head and left the original cup and liner in.

• Brand Name: UNKNOWN ACCOLADE II TMZF HA #8X 37 MM X 127 FEMORAL STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6366560
• MDR Text Key: 68597339
• Report Number: 0002249697-2017-00699
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 93