MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0637
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to a femoral periprosthetic fracture.A stem, head, and liner were revised to a restoration modular stem, a new head, and an adm/ mdm liner construct.Rep confirmed that there are no allegations against the revised head and insert.Rep reported that he can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.
Additional 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.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to a femoral periprosthetic fracture.A stem, head, and liner were revised to a restoration modular stem, a new head, and an adm/ mdm liner construct.Rep confirmed that there are no allegations against the revised head and insert.Rep reported that he can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed via clinician review of the provided x-ray.Method & results:  -device evaluation and results: no product was returned for evaluation however photographs and a x-ray was provided for review.The photographs show a recently explanted stem, head and liner.Blood and biological matter is visible on the stem, head and liner.The stem, head and liner appear unremarkable.-clinician review: a review of the provided medical records by a clinical consultant indicated: a document titled "x-ray" is provided.It is a single ap view of a right total hip replacement.There is a displaced periprosthetic fracture.The medial portion of the proximal femur is displaced." regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic fracture are multifactorial including surgical technique factors, and patient activity factors such as trauma. -device history review: a review of the device history records indicate the 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 lot referenced.Conclusion: an event regarding periprosthetic fracture involving an accolade stem was reported.A review of the provided medical records by a clinical consultant indicated: a document titled "x-ray" is provided.It is a single ap view of a right total hip replacement.There is a displaced periprosthetic fracture.The medial portion of the proximal femur is displaced." regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic fracture are multifactorial including surgical technique factors, and patient activity factors such as trauma.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF HIP STEM #6
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13664480
• Report Number: 0002249697-2022-00318
• Device Sequence Number: 20200244
• Product Code: LPH
• UDI-Device Identifier: 04546540510587
• UDI-Public: 04546540510587
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 08/31/2007
• Device Model Number: 6020-0637
• Device Catalogue Number: 6020-0637
• Device Lot Number: 4317301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male