MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0535
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2016 the patient underwent surgery of the right hip and was implanted a stryker total hip system.It is further alleged that on or about (b)(6) 2021 the patient complained of a stabbing and radiating pain in his right hip, stiffness, weakness, limited range of motion and mobility and worsening pain with activity.The patient was revised on or about (b)(6) 2021 and allegedly the surgeon intraoperatively noted " pseudotumor, trunnionosis, black stained tissue and adverse local tissue reaction" and "cup was broken loose with minimal effort" and there was no bony ingrowth.The shell, liner and femoral head were removed and replaced.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2016 the patient underwent surgery of the right hip and was implanted a stryker total hip system.It is further alleged that on or about (b)(6) 2021 the patient complained of a stabbing and radiating pain in his right hip, stiffness, weakness, limited range of motion and mobility and worsening pain with activity.The patient was revised on or about (b)(6) 2021 and allegedly the surgeon intraoperatively noted "pseudotumor, trunnionosis, black stained tissue and adverse local tissue reaction" and "cup was broken loose with minimal effort" and there was no bony ingrowth.The shell, liner and femoral head were removed and replaced.
Additional Manufacturer Narrative
An event regarding altr and wear/metallosis involving an accolade stem was reported.The event was confirmed via review of the provided medical records by a clinical consultant.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the primary operative report describes an uneventful pressfit tha.The revision operative report section for indications for procedure states that the patient had a primary tha 4 years earlier and had been painful ever since that procedure.A pre-operative x-ray demonstrated lucency about the cup.The hip in question was infiltrated with marcaine and the patient experienced immediate relief indicative a mechanical issue.Upon entering.The hip the surgeon encountered hypertrophic synovial tissue and tissue he felt was early pseudotumor.Upon removal of the 40mm femoral head the trunnion of the stem was coated in "black material.Following removal of the liner and extractor was attached to the cup and it was easily removed.Upon inspection of the ingrowth surface of the cup no bony ingrowth was identified only a layer of fibrous tissue.The revision operative report confirms that the surgeon did find what he described as early pseudotumor, trunnionosis, black stained tissue and adverse local tissue reaction.There was no bony ingrowth on the cup, only fibrous tissue.The root cause for these mechanicals complications cannot be established from this limited information provided." product history review: a review of the database indicates devices were manufactured on february 2, 2016.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 pseudotumor/altr, trunnionosis, and shell loosening.A review of the provided medical information by a clinical consultant indicated: "the primary operative report describes an uneventful pressfit tha.The revision operative report section for indications for procedure states that the patient had a primary tha 4 years earlier and had been painful ever since that procedure.A pre-operative x-ray demonstrated lucency about the cup.The hip in question was infiltrated with marcaine and the patient experienced immediate relief indicative a mechanical issue.Upon entering.The hip the surgeon encountered hypertrophic synovial tissue and tissue he felt was early pseudotumor.Upon removal of the 40mm femoral head the trunnion of the stem was coated in "black material.Following removal of the liner and extractor was attached to the cup and it was easily removed.Upon inspection of the ingrowth surface of the cup no bony ingrowth was identified only a layer of fibrous tissue.The revision operative report confirms that the surgeon did find what he described as early pseudotumor, trunnionosis, black stained tissue and adverse local tissue reaction.There was no bony ingrowth on the cup, only fibrous tissue.The root cause for these mechanicals complications cannot be established from this limited information provided." 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 5 ACCOLADE II 132 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 NJ NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12317361
• Report Number: 0002249697-2021-01380
• Device Sequence Number: 16850614
• Product Code: LPH
• UDI-Device Identifier: 04546540664488
• UDI-Public: 04546540664488
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 02/23/2021
• Device Model Number: 6720-0535
• Device Catalogue Number: 6720-0535
• Device Lot Number: 54683101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male