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); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	10/03/2019
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)2006 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device 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.
Additional Manufacturer Narrative
Reported event: an event regarding loosening, abnormal ion level, and corrosion involving an accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the implant sheet from the index surgery on (b)(6) 2011 confirms that the patient had a cocr v40 femoral head implanted.In the indications portion of the (b)(6) 2019 revision tha operative report the surgeon notes that pre-operative cobalt and chromium levels were slightly elevated at >7 and <1 respectively.Intra-operatively upon removal of the femoral head some dark material was seen on the trunnion.He stated further that after removing this material the trunnion was "grossly and structurally intact", the femoral stem had lost fixation.Both the stem and acetabulum were revised.The patient having been previously implanted with a v40 cocr head is confirmed as is a revision surgery for trunnionosis and loss of component fixation.The rott cause of the trunnionosis and loss of fixation cannot be determined from this limited documentation." -product history review: review of the device history records indicate the 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: it was reported that the patient was revised due to elevated ion levels, trunnionosis/corrosion at the stem-head interface, and aseptic loosening of the stem.A review of the provided medical information by a clinical consultant indicated: "the implant sheet from the index surgery on (b)(6) 2011 confirms that the patient had a cocr v40 femoral head implanted.In the indications portion of the (b)(6) 2019 revision tha operative report the surgeon notes that pre-operative cobalt and chromium levels were slightly elevated at >7 and <1 respectively.Intra-operatively upon removal of the femoral head some dark material was seen on the trunnion.He stated further that after removing this material the trunnion was "grossly and structurally intact", the femoral stem had lost fixation.Both the stem and acetabulum were revised.The patient having been previously implanted with a v40 cocr head is confirmed as is a revision surgery for trunnionosis and loss of component fixation.The rott cause of the trunnionosis and loss of fixation cannot be determined from this limited documentation." further information such as return of the device, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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), 2006 and was revised on (b)(6), 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Update (b)(6) 2022 mf: per provided medical records: "the hip did in fact have trunnionosis and there was a moderate amount of blackish material at the femoral neck/head junction and, however, the trunnion for the most part was still grossly intact and structurally intact [.] when the stem was checked for rotational stability, there were bubbles and fluid coming out of the proximal interface between the femoral stem and the bone and this obviously was indicative of a femoral of a fibrous interface and there was aseptic loosening present.[.] the acetabular component was completely well fixed and did not have evidence of osteolysis or erosion, but the polyethylene did have slight yellowish color due to what appeared to be some early oxidation and there was also some scratching of the polyethylene." there were no reported allegations against the shell, and it was revised to a competitor device.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14073769
• Report Number: 0002249697-2022-00508
• Device Sequence Number: 14939441
• Product Code: LPH
• UDI-Device Identifier: 04546540510778
• UDI-Public: 04546540510778
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 04/30/2016
• Device Model Number: 6021-5537
• Device Catalogue Number: 6021-5537
• Device Lot Number: 36584402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2011
• 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: 77 YR
• Patient Sex: Male