MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6020-4535
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Edema (1820); Discomfort (2330); Injury (2348); Osteolysis (2377); Reaction (2414)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Condition after implantation of an accoldade shaft with v40 head, development of a large pseudotumor in the groin area due to known cone problems in this implant combination.Surgeon forwarded us the following information: in summary, the incident is the following situation: (b)(6).In 2007 implantation of a cementless hip endoprosthesis (accolade, trident, metal head -0.5, article numbers according to surgical report).Development of local metal intolerance with large "pseudotumor" / armd in the left hip with compression of the iliac vein presumably in the years 2014 to 2107 of increasing size.Currently 2017/2018 increasing local discomfort in the left hip joint.Metal value increase with cobalt in whole blood 6,89 ¿g / l (reference range 0,5-3,9 ¿g / l) at normal chromium values ¿¿(0,62 ¿g / l at reference value 0,5 to 4,0 ¿g / l in whole blood).X-ray increasing osteolysis in the cup area, in ct and mri mri , formation of a large pseudotumor both in the area of ¿¿the outside hip muscles and in the retroperitoneum around the iliacus muscle.Due to increasing complaints, the resection of the pseudotumor with head and inlay changes took place on (b)(6) 2018 (clear conical corrosion visible without any indication of relevant substance defect.) therefore change to v40 titanium adapter for delta ceramic module head 36 mm).The patient wanted the implants to be delivered, which is why a transfer of the removed head and inlay after sonication is not possible.
Additional Manufacturer Narrative
An event regarding altr involving an accolade stem was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: review of these records confirms metallosis and development of a pseudotumor about the tha occurred, however, the root cause cannot be determined as insufficient information was available.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a review by the clinician stated: review of these records confirms metallosis and development of a pseudotumor about the tha occurred, however, the root cause cannot be determined as insufficient information was available.Documentation which would aid in the further completion of this assessment would include: implant retrieval with material analysis, dated pre and post op x-rays/ imaging from the index and revision surgeries, surgical pathology reports, laboratory reports and outpatient office/clinic notes.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Condition after implantation of an accolade shaft with v40 head, development of a large pseudotumor in the groin area due to known cone problems in this implant combination.Surgeon forwarded us the following information: in summary, the incident is the following situation: patient (b)(6), (b)(6) years, currently 178 cm height and (b)(6) body weight.Anamnese: 2007 implantation of a cementless hip endoprosthesis (accolade, trident, metal head -0.5, article numbers according to surgical report).Development of local metal intolerance with large "pseudotumor" / armd in the left hip with compression of the iliac vein presumably in the years 2014 to 2107 of increasing size.Currently 2017/2018 increasing local discomfort in the left hip joint.Metal value increase with cobalt in whole blood 6,89 ug / l (reference range 0,5-3,9 g / ul) at normal chromium values (0,62 ug / l at reference value 0,5 to 4,0 ug / l in whole blood).X-ray increasing osteolysis in the cup area, in ct and mri, formation of a large pseudotumor both in the area of the outside hip muscles and in the retroperitoneum around the iliacus muscle.Due to increasing complaints, the resection of the pseudotumor with head and inlay changes took place on (b)(6) 2018 (clear conical corrosion visible without any indication of relevant substance defect.) therefore change to v40 titanium adapter for delta ceramic module head 36 mm).The patient wanted the implants to be delivered, which is why a transfer of the removed head and inlay after sonication is not possible.

• Brand Name: ACCOLADE 132 SIZE 4.5
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7797158
• Report Number: 0002249697-2018-02570
• Device Sequence Number: 2050019
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 06/30/2011
• Device Catalogue Number: 6020-4535
• Device Lot Number: 19181203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 76 YR
• Patient Weight: 77