MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock on with no reported relevant discrepancies.Based on the device identification the complaint databases for similar reported events regarding abnormal ion level.There have been no other similar events for the lot referenced.Device not returned to manufacturer.
Event or Problem Description
A representative from the clinic reported the following event: "installation of an abg il hip prosthesis: allergy to metals.".
Additional Manufacturer Narrative
This event is related to voluntary recall ra 2012-067.This recall was initiated due to the potential risks associated with modular neck stems.The stem and neck will undergo a full investigation.This device has been identified as a non-contributor to the event.
Event or Problem Description
A representative from the clinic reported the following event : "installation of an abg il hip prosthesis: allergy to metals".

• Brand Name: 28MM STD V40 TAPER VIT HEAD
• 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: 8245227
• Report Number: 0002249697-2019-00166
• Device Sequence Number: 2370856
• Product Code: JDI
• UDI-Device Identifier: 07613327012866
• UDI-Public: 07613327012866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: 11/30/2013
• Device Catalogue Number: 6260-5-128
• Device Lot Number: 28553904
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/13/2019
• 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