MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ACCOLADE I STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

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.The mitch trh acetabular system components are oem devices.Stryker orthopaedics is not the legal manufacturer of the mitch devices and does not have reporting responsibilities.However, since this device was used in conjunction with a stryker device, the product information for this device is being referenced in this mdr report - unknown lot, unknown mitch device.

Event Description

An article by hip international, "catastrophic failure of the accolade i hip arthroplasty stem: a retrieval analysis study" presents the following case example: "a (b)(6) year old male presented to our tertiary centre in (b)(6) 2016 with hip pain and inability to weight bear.He had undergone a right total hip arthroplasty for osteoarthritis 7.1 years prior.The components used were an accolade i stem in combination with a mitch trh 54mm head.X-rays demonstrated catastrophic failure of components (head neck dissociation, gross metallosis, trunnionosis, fretting and trunnion failure).Macroscopic evaluation revealed excellent bone ongrowth to the femoral stem (proximally), however, numerous metallic particles embedded in the tissue (consistent with metallosis), destructive wear of the femoral taper (trunnion) with marked superolateral wear and inferomedial notching of the neck.The femoral head showed severe wear of the bearing surface and extensive erosion.".

• Brand Name: UNKNOWN_ACCOLADE I STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10274983
• MDR Text Key: 200774616
• Report Number: 0002249697-2020-01449
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/15/2020
• 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: 68 YR