MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO7 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0107
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Fracture of the femoral head.The fracture occurred when the patient turned while standing.Device was implanted in 2001.
Additional Manufacturer Narrative
An event regarding ceramic head crack/fracture involving an abg ii stem was reported.With the limited information available upon initial receipt of this event, the decision was made to report the stem.On completion of the investigations and clinical review based on the information provided there is no indication or allegation that the reported stem contributed to the event.Further review of all available information indicates that the stem was not a cause or contributor to the patient¿s experience, therefore the stem is determined to be concomitant.
Event or Problem Description
Fracture of the femoral head.The fracture occurred when the patient turned while standing.Device was implanted in 2001.

• Brand Name: ABGII NO7 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: 10725776
• Report Number: 0002249697-2020-02224
• Device Sequence Number: 19361332
• Product Code: LPH
• UDI-Device Identifier: 07613327050974
• UDI-Public: 07613327050974
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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 Model Number: 4845-0107
• Device Catalogue Number: 4845-0107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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: 66 YR
• Patient Weight: 150