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

Model Number	7000-6602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Mps planned size 2 insignia stem for 4.1 tha mako case.Reviewed plan with surgeon prior to him scrubbing in.While broaching with size 1, surgeon wanted to see a size 1 on mako plan, then continued to broach to a size 2 noting it was a better fit.Trailed with size 2.Landmarks captured, hip length longer than goal.Surgeon calcar reamed with size 1 broach and then did not return to size 2 broach while trailing.Continued on trailing with size 1 without mps knowledge.Presented size 2 insignia high offset implant box and head to surgeon, reading out parts and sizes.Surgeon looked up at boxes and acknowledged correct and to open boxes.No following landmarks were captured to attain final length and offset.Surgeon closed patient without concern.Card was handed to surgeon containing final length and offset numbers as well as implant stickers.Upon examining post op xr prior to patient leaving or, surgeon determined pt leg length to be longer than goal.Surgeon contacted mps noting he wanted a size 1 stem not a 2 and he wants to open patient up again and switch to size 1 stem.Pt was opened and stem was switched to size 1 from 2 and a new biolox 36mm +0 head was implanted.Upon further discussion with or manager, surgeon's pa noted final stem seemed to sit proud of trial and questioned size but surgeon was not concerned.Nurse and scrub techs recall mps calling out and presenting implants to surgeon.
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.H3 other text : not returned.

• Brand Name: HIGH 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17076217
• Report Number: 0002249697-2023-00634
• Device Sequence Number: 6273572
• Product Code: LPH
• UDI-Device Identifier: 07613327511543
• UDI-Public: 07613327511543
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K211703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: 7000-6602
• Device Catalogue Number: 7000-6602
• Device Lot Number: 96760501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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 Sex: Unknown