MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0330
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.Revised a left total hip originally done by mako.The stem was not put in correctly originally.The cup wasn't fully stable when assessed.Everything was replaced with competitor components.No allegations against the implants.Update 10/february/2022 (b)(4): rep provided the following response when asked if the shell was implanted in the position it was found in, or if it had shifted: "the cup was not shifted and was in the location as planned with mako.Dr.Uses a manual reamer with smaller sizes up through one under, and then uses mako for only the final size.It was suspected that was the cause for the cup possibly not being fully seated as it's possible he manually reamed deeper than mako plan or off center.".
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.
Event or Problem Description
Dr.Revised a left total hip originally done by mako.The stem was not put in correctly originally.The cup wasn't fully stable when assessed.Everything was replaced with competitor components.No allegations against the implants.Update 10/february/2022 wg: rep provided the following response when asked if the shell was implanted in the position it was found in, or if it had shifted: "the cup was not shifted and was in the location as planned with mako.Dr.Uses a manual reamer with smaller sizes up through one under, and then uses mako for only the final size.It was suspected that was the cause for the cup possibly not being fully seated as it's possible he manually reamed deeper than mako plan or off center.".
Additional Manufacturer Narrative
Reported event: an event regarding subsidence involving a accolade stem was reported.The event was confirmed by a clinical consultant review.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records by clinical consultant indicated " the femoral component most likely was undersized which allowed for subsidence and the lateral cortex must have breached and the distal stem went out the lateral cortex.I can confirm that this event took place since i was able to review the xray showing the subsided femoral component whose distal stem is extraosseous.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of a femoral component protruding through the cortex is caused by poor directional broaching.Subsidence is due to using an implant that is too small for the envelope created.While the use of the mako robot for the cup can assure proper depth and version and inclination, it is the surgeon who is in control.Using multiple small reamers manually can result in poor preparation of the socket.This failure is iatrogenic and not mako related." -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 stem was not put in correctly originally".A review of medical records by clinical consultant indicated " the femoral component most likely was undersized which allowed for subsidence and the lateral cortex must have breached and the distal stem went out the lateral cortex.I can confirm that this event took place since i was able to review the xray showing the subsided femoral component whose distal stem is extraosseous.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of a femoral component protruding through the cortex is caused by poor directional broaching.Subsidence is due to using an implant that is too small for the envelope created.While the use of the mako robot for the cup can assure proper depth and version and inclination, it is the surgeon who is in control.Using multiple small reamers manually can result in poor preparation of the socket.This failure is iatrogenic and not mako related".No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 3 ACCOLADE II 127 DEG
• 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: 13665796
• Report Number: 0002249697-2022-00328
• Device Sequence Number: 4893622
• Product Code: LPH
• UDI-Device Identifier: 04546540669483
• UDI-Public: 04546540669483
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 04/30/2026
• Device Model Number: 6721-0330
• Device Catalogue Number: 6721-0330
• Device Lot Number: 84195102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: 60 YR
• Patient Sex: Male