MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS RIGHT V40

Catalog Number	4845-0105
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
10 years after implantation ((b)(6) 2009) there is a disconnection of the stem from the prosthesis head.There was no trauma.The stem and acetabulum are tight.The prosthesis head remains in the acetabulum.Prosthesis head: lfit anatomic v40 femoral head 36 + 5 mm ref 6260-9-236, lot mer43w, sn (b)(4).

• Brand Name: ABGII NO5 CEMENTLESS RIGHT V40
• Common Device Name: ABGII NO5 CEMENTLESS RIGHT V40
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8827906
• Report Number: 0002249697-2019-02675
• Device Sequence Number: 14094039
• Product Code: LPH
• UDI-Device Identifier: 07613327050943
• UDI-Public: 07613327050943
• Combination Product (Y/N): N
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 07/31/2013
• Device Catalogue Number: 4845-0105
• Device Lot Number: G2596059E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/25/2019
• 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: Other
• Patient Age: 60 YR