MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6720-0127

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

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.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.Not available.

Event Description

This is to bring your notice that there was a surgery for thr on (b)(6) 2020.During the surgery initially dr decided to use accolade ii(size 1) with ceramic head.But unfortunately the ceramic head did not fit well with our stem and it was coming out every time he was trying to fit.Dr found so many scratches inside the ceramic head.So he decided to use metal head but the metal head also did not fit with the stem.So finally dr replaced the stem to accolade ii(size 2) and tried with metal head and it fitted well.During the surgery dr analyzed that the tapper size of accolade ii(size 1) was not correct and i.E both the head did not fit well.So requesting you please suggest how to go ahead as the dealer is having two unused implants(1-accolade ii size 1,2-ceramic head) which was opened inside ot.I am attaching the photographs and product enquiry intake form for your reference.

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving an accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: the stem with packaging was returned for evaluation.The taper was heavily scratched, which was consistent with damage of attempted implantation of femoral head.Nothing else remarkable to report.The taper feature was inspected twice within the process (post machining/post handfinish) and all gauging was found to be within specification.Dimensional inspection on the taper was re-inspected on 17-sep-2020 and it was determined that the accolade ii size 1 taper (p/n: 6720-0127 lot id :63303801) is fully within specification for the taper locking feature and that the accolade ii part is not a root cause for incident.-medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: dhr review showed that all devices in the lot referenced were accepted into final stock with no relevant reported discrepancies.Complaint history review: there were no similar events for the lot referenced.Conclusions: the stem with packaging was returned for evaluation.The taper was heavily scratched, which was consistent with damage of attempted implantation of femoral head.The taper feature was inspected twice within the process (post machining/post handfinish) and all gauging was found to be within specification.Dimensional inspection on the taper was re-inspected on 17-sep-2020 and it was determined that the accolade ii size 1 taper is fully within specification for the taper locking feature and that the accolade ii part is not a root cause for incident.No further investigation for this event is possible at this time.If additional information become availables this record will be reopened.

Event Description

This is to bring your notice that there was a surgery for thr on (b)(6) 2020.During the surgery initially dr decided to use accolade ii(size 1) with ceramic head.But unfortunately the ceramic head did not fit well with our stem and it was coming out every time he was trying to fit.Dr found so many scratches inside the ceramic head.So he decided to use metal head but the metal head also did not fit with the stem.So finally dr replaced the stem to accolade ii(size 2) and tried with metal head and it fitted well.During the surgery dr analyzed that the tapper size of accolade ii(size 1) was not correct and i.E both the head did not fit well.So requesting you please suggest how to go ahead as the dealer is having two unused implants(1-accolade ii size 1,2-ceramic head) which was opened inside ot.I am attaching the photographs and product enquiry intake form for your reference.

• Brand Name: SIZE 1 ACCOLADE II 132 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9954278
• MDR Text Key: 188980632
• Report Number: 0002249697-2020-00738
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540664440
• UDI-Public: 04546540664440
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 6720-0127
• Device Catalogue Number: 6720-0127
• Device Lot Number: 63303801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other