MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-5537
Medical Device Problem Codes	Corroded (1131); Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2015 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.
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.Not available.
Additional Manufacturer Narrative
An event regarding abnormal ion level, corrosion and wear (trunnionosis) involving an accolade stem was reported.The events were confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: "the implant sheet confirms that the patient had a cocr v40 femoral head implanted.In the indications portion of the operative report the surgeon notes that pre-operative cobalt and chromium levels were slightly elevated at 3.6 and 0.8 respectively.A pre-operative mri showed a fluid collection and particulate debris.These mri findings were corroborated at the time of surgery.Upon removal of the femoral head some "fouling " was noted on the trunnion.He stated further that this fouling was easily wiped away with a wet sponge and the trunnion was "intact" the patient having been previously implanted with a v40 cocr head is confirmed as is a revision surgery for trunnionosis.The indications section of the operative record reports minimal pre-operative serum metallic ion elevations and a pre-operative mri showed fluid with particulate debris, in the operative report the surgeon describes this fluid and debris as "like wet cat food".With this limited information the root cause of this issue cannot be determined." -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: a review of the provided medical information by a clinical consultant indicated: "the implant sheet confirms that the patient had a cocr v40 femoral head implanted.In the indications portion of the operative report the surgeon notes that pre-operative cobalt and chromium levels were slightly elevated at 3.6 and 0.8 respectively.A pre-operative mri showed a fluid collection and particulate debris.These mri findings were corroborated at the time of surgery.Upon removal of the femoral head some "fouling " was noted on the trunnion.He stated further that this fouling was easily wiped away with a wet sponge and the trunnion was "intact" the patient having been previously implanted with a v40 cocr head is confirmed as is a revision surgery for trunnionosis.The indications section of the operative record reports minimal pre-operative serum metallic ion elevations and a pre-operative mri showed fluid with particulate debris, in the operative report the surgeon describes this fluid and debris as "like wet cat food".With this limited information the root cause of this issue cannot be determined." 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.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6), 2015 and was revised on (b)(6), 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.

• Brand Name: ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5
• 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: 14520826
• Report Number: 0002249697-2022-00774
• Device Sequence Number: 6530308
• Product Code: LPH
• UDI-Device Identifier: 04546540510778
• UDI-Public: 04546540510778
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 02/12/2020
• Device Model Number: 6021-5537
• Device Catalogue Number: 6021-5537
• Device Lot Number: 50456304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• 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 Sex: Male