MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6721-0635

Device Problems Mechanical Problem (1384); Fitting Problem (2183); Loss of Osseointegration (2408); Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 08/20/2020

Event Type  Injury  

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

Subject reported anterior hip pain with significant limp on (b)(6) 2019.Per subject, experiencing same pain and issues as before surgery.Event is unresolved and ongoing.Subject instructed to limit weight bearing activities while walking.Update 26/august/2020 wg: additional information provided by study site: "(b)(6) 2019 clinic notes indicate some "mild discomfort" but "nothing significant." however, (b)(6) 2019 notes indicate "significant thigh pain" about "3 weeks ago," from yard work.From (b)(6) 2019 through present in emr, this event is diagnosed as stem subsidence.Xray reviews noted stem subsidence and ossification (b)(6) 2019.Ct: possible lack of ingrowth w hypertrophy around stem.Partial weight bearing with walker, stop p.T.(b)(6) 2019, (b)(6) 2019 , & (b)(6) 2019 notes indicate pain but subj continues to ambulate and perform adls.(b)(6) 2020 xrays: further subsidence "unable to walk any distance.".(b)(6) 2020 notes: aseptic loosening confirmed.Revision planned (b)(6) 2020.".

Event Description

Subject reported anterior hip pain with significant limp on (b)(6) 2019.Per subject, experiencing same pain and issues as before surgery.Event is unresolved and ongoing.Subject instructed to limit weight bearing activities while walking.Update (b)(6) 2020 wg: additional information provided by study site: "(b)(6) 2019 clinic notes indicate some "mild discomfort" but "nothing significant." however, (b)(6) 2019 notes indicate "significant thigh pain" about "3 weeks ago," from yard work.From (b)(6) 2019 through present in emr, this event is diagnosed as stem subsidence.Xray reviews noted stem subsidence and ossification (b)(6) 2019.Ct: possible lack of ingrowth w hypertrophy around stem.Partial weight bearing with walker, stop p.T.(b)(6) 2019, (b)(6) 2019 , & (b)(6) 2019 notes indicate pain but subj continues to ambulate and perform adls.(b)(6) 2020 xrays: further subsidence "unable to walk any distance.".(b)(6) 2020 notes: aseptic loosening confirmed.Revision planned (b)(6) 2020.".

Manufacturer Narrative

Reported event: an event regarding subsidence, loosening, rom and size/fit issue involving a trident shell was reported.The event of subsidence and loosening was confirmed through clinician review.Rom and size/fit issue were not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: stem subsidence/aseptic loosening leading to pain and scheduled revision surgery.The assessment was confirmed.The stem subsided and appeared aseptic loose.The stem was likely undersized at the index procedure and was not initially stable leading to failure to ingrow/ongrow.Obtaining the implant may provide insight into the mechanics of failure.-device history review: all 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 reported lot.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: stem subsidence/aseptic loosening leading to pain and scheduled revision surgery.The assessment was confirmed.The stem subsided and appeared aseptic loose.The stem was likely undersized at the index procedure and was not initially stable leading to failure to ingrow/ongrow.Obtaining the implant may provide insight into the mechanics of failure.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 6 ACCOLADE II 127 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: 10538577
• MDR Text Key: 207342864
• Report Number: 0002249697-2020-01920
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669513
• UDI-Public: 04546540669513
• 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
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 6721-0635
• Device Catalogue Number: 6721-0635
• Device Lot Number: 69312201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 87