MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection and metallosis involving an accolade stem was reported.The event was not confirmed method & results: product evaluation and results: not performed as no product was returned for evaluation - it remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been one other similar event for the reported lot and sterile lot.The other event relates to the same device/patient, therefore no further trending is required for this commonality conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology, progress notes, x-rays and evaluation of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
This pi is for periprosthetic infection- metallosis and bone puncture done on (b)(6) 2017.It was reported through the filing of a lawsuit that allegedly the (b)(6) 2017 cup and liner exchange "did not resolve the problems and on (b)(6) 2017 the patient was readmitted because of a hip infiltration (periprosthetic infection-metallosis), requiring a bone puncture.Patient did not get better.On (b)(6) 2017 her surgeons removed the stryker stem and femoral head and replaced all of the stryker components except the cup and liner already replaced in the [previous surgery].".
Additional Manufacturer Narrative
The following devices were also listed in this report: unknown shell; cat#unk ; lot#unk.Unknown liner; cat#unk ; lot#unk.Alumina v40-femoral head 28mm, +4mm nk; cat#6565-0-228; lot#27167702.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for periprosthetic infection- metallosis and bone puncture done on (b)(6) 2017.It was reported through the filing of a lawsuit that allegedly the (b)(6) 2017 cup and liner exchange "did not resolve the problems and on (b)(6) 2017 the patient was readmitted because of a hip infiltration (periprosthetic infection-metallosis), requiring a bone puncture.Patient did not get better.On (b)(6) 2017 her surgeons removed the stryker stem and femoral head and replaced all of the stryker components except the cup and liner already replaced in the [previous surgery]".

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8375342
• Report Number: 0002249697-2019-01214
• Device Sequence Number: 19382612
• Product Code: LPH
• UDI-Device Identifier: 04546540510655
• UDI-Public: 04546540510655
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 07/31/2011
• Device Catalogue Number: 6021-0030
• Device Lot Number: 19201301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/08/2019
• 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; Required Intervention