MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-236
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Date of Event	11/09/2019
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.Device not returned.
Event or Problem Description
As reported: "patient had primary right total hip completed on (b)(6) 2019.Patient fell and heard pop while going to the bathroom on (b)(6) 2019 [exam note and operative report state "patient got up to go to the bathroom with his walker, lost balance and fell, landing hard on his knee, 'bending like an accordion' with right knee bent suddenly to chest.Immediate onset of severe sharp right hip and groin pain, radiating down right leg, worse with touch or move, no alleviating factors"].Patient booked for surgery on (b)(6) 2019 - periprosthetic femur fracture.Doctor removed the femoral stem and head by hand - he noted that he was able to separate the head from the stem by hand.He asked post-surgery to have stryker look at this ceramic head.He was unsure why it came apart by hand.He reduced the fracture and placed 3 cables.He re-inserted the original stem back to its original placement.He trialed a 36 +5 trial head and found it to be adequate.A 36 +5 cocr head was impacted on.A history and physical and post-operative report will follow.The biolox explant head will be sent back and no further information will be available.".

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+5
• 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: 9433524
• Report Number: 0002249697-2019-03972
• Device Sequence Number: 1711047
• Product Code: JDI
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: 12/31/2006
• Device Catalogue Number: 6570-0-236
• Device Lot Number: 73041701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 12/06/2019
• 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
• Patient Age: 50 YR