MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO2 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	4845-0102
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.Not available.
Event or Problem Description
Update (b)(6) 2018: following a review of the images in the provided medical records the event relates to the crack fracture of an abgii stem.
Additional Manufacturer Narrative
This record is a duplicate of 0002249697-2017-01375.Therefore, this record is being cancelled.
Event or Problem Description
Update (b)(6) 2018: following a review of the images in the provided medical records the event relates to the crack fracture of an abgii stem.

• Brand Name: ABGII NO2 CEMENTLESS RIGHT V40
• 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: 7968669
• Report Number: 0002249697-2018-03351
• Device Sequence Number: 19136223
• Product Code: LPH
• UDI-Device Identifier: 07613327050967
• UDI-Public: 07613327050967
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 04/30/2013
• Device Catalogue Number: 4845-0102
• Device Lot Number: G2093077ER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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; Required Intervention
• Patient Age: 64 YR