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

Catalog Number	7000-5505
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.H3 other text : device not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's right (mako) hip was revised due to pain and subsidence (rep confirmed there was no bone fracture).Surgeon noted and was concerned that there was little bone ongrowth on the stem intra-operatively and wants an investigation.The stem and head were revised.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence involving an insignia stem was reported.The event was confirmed via clinician review of provided medical records.Method & results: -product evaluation and results: the reported device was not returned however a photograph was provided for review.The photo shows what appears to be blood, tissue, and spots of white material adhered to the ha coated portion of the stem.The white material appears to be evidence of bony ingrowth but that cannot be concluded from the photograph alone.The stem otherwise appears undamaged.There is nothing further remarkable to note.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this 71-year-old female underwent a right mako assisted total hip arthroplasty and was revised 3 1/2 months later for subsidence where little bone on growth was noted.The root cause of this event cannot be determined with certainty.The causes of early subsidence are multifactorial including surgical technique factors including proper preparation and proper determination of implant size, as well as patient factors such as bone quality, activity level and bmi.With the information provided i would not assign any causality to the implant itself." 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: it was reported that the patient was revised due to stem subsidence.A review of the provided x-rays and medical records by a clinical consultant confirmed the event and indicated the following: "this 71-year-old female underwent a right mako assisted total hip arthroplasty and was revised 3 1/2 months later for subsidence where little bone on growth was noted.The root cause of this event cannot be determined with certainty.The causes of early subsidence are multifactorial including surgical technique factors including proper preparation and proper determination of implant size, as well as patient factors such as bone quality, activity level and bmi.With the information provided i would not assign any causality to the implant itself." the reported device was not returned however a photograph was provided for review.The photo shows what appears to be blood, tissue, and spots of white material adhered to the ha coated portion of the stem.The white material appears to be evidence of bony ingrowth but that cannot be concluded from the photograph alone.The stem otherwise appears undamaged.There is nothing further remarkable to note.No further investigation for this event is possible at this time.If devices and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right (mako) hip was revised due to pain and subsidence (rep confirmed there was no bone fracture).Surgeon noted and was concerned that there was little bone ongrowth on the stem intra-operatively and wants an investigation.The stem and head were revised.

• Brand Name: STANDARD INSIGNIA COLLARED HIP STEM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17393304
• Report Number: 0002249697-2023-00833
• Device Sequence Number: 8941880
• Product Code: LPH
• UDI-Device Identifier: 07613327511604
• UDI-Public: 07613327511604
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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 Catalogue Number: 7000-5505
• Device Lot Number: 97621903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 85 KG