MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-128
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/10/2020
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
The patient had already a accolade ii stem and a titanium cup.The surgeon wanted to replace the head and insert by a constrained liner and new head.When both implants were placed, the surgeon tested stability, but the bipolar head of the constrained liner became loose from the liner.When he removed the ceramic head from the stem , the head broke.To solve all this , we took another constrained liner , with a metal 22mm head.Update per response: surgical delay 1 hour.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed through visual inspection.Method & results -product evaluation and results: visual inspection of the returned device noted the following: the macroscopic surface features are consistent with an overload fracture propagating outward and longitudinally.This type of fracture pattern is created by overload hoop stresses caused by the wedge effect of the stem trunnion material analysis of the returned device noted the following: the returned ceramic head had fractured.The head likely fractured due to hoop stresses caused by the wedge effect.A continuous metal transfer ring was observed at the proximal end of the head taper.Base on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the device fractured due to overload.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the operative report and further interviews from the user are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The patient had already a accolade ii stem and a titanium cup.The surgeon wanted to replace the head and insert by a constrained liner and new head.When both implants were placed , the surgeon tested stability , but the bipolar head of the constrained liner became loose from the liner.When he removed the ceramic head from the stem , the head broke.To solve all this , we took another constrained liner , with a metal 22mm head.Update per response: surgical delay 1 hour.

• Brand Name: DELTA V-40 CERAMIC HEAD 28/0
• 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: 9671658
• Report Number: 0002249697-2020-00232
• Device Sequence Number: 16238128
• Product Code: JDI
• UDI-Device Identifier: 04546540608499
• UDI-Public: 04546540608499
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173499
• 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): 05/29/2020

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: 09/30/2024
• Device Model Number: 6570-0-128
• Device Catalogue Number: 6570-0-128
• Device Lot Number: 74814903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2019
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 05/29/2020
• 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: 70 YR