MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6720-0837
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
An mdm insert and 28 biolox head were put together on the back table using the mdm instrumentation.After assembly the head was checked to make sure the 28 inner head moved freely inside the insert.The surgeon proceeded to implant with the correct head pusher from the set and the insert and head disassociated during hip reduction.Update 31/october/2019 wg: spoke to rep.The following sequence of event occurred during a primary right hip procedure: a femoral head disassociated from an adm/ mdm insert during reduction.A second femoral head and adm/ mdm insert were assembled.Patient factors (reported by the surgeon as a combination of the patient's weight and spinal problems.These factors apply to the next two pairs of heads and liners) prohibited the hip from being reduced, and the patient's femur fractured.The accolade ii stem was revised to a restoration modular stem construct with dall- miles cable sets.A third pair of femoral head and adm/mdm insert were assembled at the back table, aforementioned patient factors prohibited the hip from being reduced.A fourth pair of adm/ mdm insert and femoral head were assembled at the back table, aforementioned patient factors prohibited the hip from being reduced.Finally, a 36 -5 lfit femoral head and 36f poly liner were successfully implanted in the patient.Rep reported the surgeon predominantly uses stryker implants, and was trained by an hcp who is a stryker consultant.Rep has provided the usage sheet and implant stickers for the first pair of head and insert.Rep confirmed there are no allegations against the revised mdm liner, accolade ii stem, or universal v40 adapter sleeve and twice confirmed surgery was completed successfully with a delay of approximately 2 minutes.

• Brand Name: SIZE 8 ACCOLADE II 132 DEG
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9385726
• Report Number: 0002249697-2019-03911
• Device Sequence Number: 2385433
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: 04546540664518
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: 06/30/2024
• Device Catalogue Number: 6720-0837
• Device Lot Number: 71966101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/27/2019
• 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: 67 YR