MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2041C-3250
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding crack/fracture involving a other hip liner was reported.The event was confirmed via clinician review.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: (b)(6) 2020: operative note.Damaged femoral head secondary to failed acetabular component.Revision polyethylene.Placed 100 poly, 32mmid, head 32mm +8mm.Fluid in ¿knee¿ was black clear.Tremendous metallosis and black synovium in joint.Broken pieces of old acetabulum removed.Locking wire free and removed.Head removed.Head was articulating with the metal shell.Both were worn.Stem well fixed.Trials placed.Slight corrosion on the taper.New liner placed.Hip not stable on initial trialing.So used longer neck, so needed metal head.Closed.Confirmation: a revision surgery event could be confirmed.Injuries as a result of implantation and explantation, device recall and/or excessive levels of chromium and cobalt could not be confirmed.Root cause: a root cause could not be ascertained without additional medical records or confirmation of the events.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: it was reported that the patient's hip was revised due to damaged femoral head secondary to failed acetabular component.Tremendous metallosis and black synovium in joint.Broken pieces of old acetabulum removed.Locking wire free and removed.Slight corrosion on the taper.Clinician review confirmed that the revision surgery for damaged femoral head secondary to failed acetabular component was performed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and 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 right hip on or about (b)(6) 2012 and was revised on (b)(6) 2020.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.*update on 20-oct-2021 based on op reports: "[¿] diagnosis: [¿] damaged femoral head secondary to failed acetabular component [¿] procedure details [¿] there was a tremendous amount of metallosis and black synovium within the joint.[¿] the broken pieces of probably from the old acetabulum were immediately identified and removed along with a free piece of wire from the old marker.[¿] ".

• Brand Name: CROSSFIRE 10 DEG INSERT
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12779299
• Report Number: 0002249697-2021-01865
• Device Sequence Number: 5749518
• Product Code: LPH
• UDI-Device Identifier: 04546540035790
• UDI-Public: 04546540035790
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 05/31/2016
• Device Model Number: 2041C-3250
• Device Catalogue Number: 2041C-3250
• Device Lot Number: 36902601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2011
• 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: 51 YR
• Patient Sex: Male