MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	509-02-54E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: acetabular dome hole plug; cat# 2060-0000-1; lot# mkka3r.Gap plate screws; cat# 2080-0015; lot# mkk44h.Gap plate screws; cat# 2080-0020; lot# mkeknh.Gap plate screws; cat# 2080-0020; lot# mkhh6j.Gap plate screws; cat# 2080-0025; lot# mka5rm.Gap plate screws; cat# 2080-0025; lot# mkjp14.Trident 0 deg insert 40mm; cat# 623-00-40e; lot# mkn951.V40 cocr lfit head 40mm/+0; cat# 6260-9-140; lot# mkjt8m.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device evaluated by manufacturer? not returned.
Event or Problem Description
This pi is for the revision of the patient's hip in or after (b)(6) 2014 [removal of primary implants except rejuvenate modular stem and neck].Event as per form: in reporting a revision of the patient's hip on (b)(6) 2020, it was discovered that the patient's original shell, screws, dome hole plug, liner, and femoral head were revised to another femoral head and competitor acetabular components.Reason and date of the revision are unknown but based on the release date of the implanted femoral head, surgery would have taken place in or after (b)(6) 2014.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM REVISION ACETABULAR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10975435
• Report Number: 0002249697-2020-02603
• Device Sequence Number: 19008471
• Product Code: JDI
• UDI-Device Identifier: 07613327025149
• UDI-Public: 07613327025149
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 509-02-54E
• Device Catalogue Number: 509-02-54E
• Device Lot Number: MKE0J1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/09/2020
• 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
• Patient Age: 77 YR