MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STANDARD INSIGNIA COLLARED HIP STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	7000-5503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Right greater trochanter fracture intraoperative.Initially being managed conservatively.Scheduled orif possible revision tha (b)(6) 2022.Update: "bone observed to be fractured by one of the investigators (b)(6) 2022 via x-ray imaging.No instruments or implants were in contact with the bone when it was observed to be fractured.X-ray imaging occurred to conclude fracture at emergency department (b)(6) 2022.The revision surgery has been cancelled and subject is being treated conservatively and being rechecked in 3 weeks for further evaluation.".
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.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a other hip stem was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical documents concluded: "it is confirmed that the patient experienced a spontaneous greater trochanteric about a cementless tha.There was no fall or trauma.The root cause of this fracture cannot be established with this limited documentation." product history review: review of the device history records indicate 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.Conclusions: a review of the provided medical documents concluded: "it is confirmed that the patient experienced a spontaneous greater trochanteric about a cementless tha.There was no fall or trauma.The root cause of this fracture cannot be established with this limited documentation." the exact cause of the event could not be determined.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Right greater trochanter fracture intraoperative.Initially being managed conservatively.Scheduled orif possible revision tha (b)(6) 2022.Update: "bone observed to be fractured by one of the investigators (b)(6) 2022 via x-ray imaging.No instruments or implants were in contact with the bone when it was observed to be fractured.X-ray imaging occurred to conclude fracture at emergency department (b)(6) 2022.The revision surgery has been cancelled and subject is being treated conservatively and being rechecked in 3weeks for further evaluation." update:(b)(6) 2022 "the revision surgery has been cancelled and subject is being treated conservatively and being rechecked in 3weeks for further evaluation." update: op note date (b)(6) 2022 "subject is doing good, no revision surgery warranted at this time.".

• Brand Name: STANDARD INSIGNIA COLLARED HIP STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15749272
• Report Number: 0002249697-2022-01593
• Device Sequence Number: 6364052
• Product Code: JDI
• UDI-Device Identifier: 07613327511413
• UDI-Public: 07613327511413
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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 Model Number: 7000-5503
• Device Catalogue Number: 7000-5503
• Device Lot Number: 91723203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White