MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-232
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that the femoral head would not properly seat on the trunnion of the accolade ii stem.Another femoral head of the same catalog number (different lot) was used and seated on the trunnion properly.A surgical delay of approximately 2 minutes was caused.Rep has the implant but could not retrieve any of the packaging as it had been disposed by hospital staff.
Event or Problem Description
Primary procedure, right hip.It was reported that the femoral head would not properly seat on the trunnion of the accolade ii stem.Another femoral head of the same catalog number (different lot) was used and seated on the trunnion properly.A surgical delay of approximately 2 minutes was caused.Rep has the implant but could not retrieve any of the packaging as it had been disposed by hospital staff.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a ceramic head was reported.The event was not confirmed.Conclusion: the event and exact cause of the event could not be confirmed or determined because insufficient information was provided.Additional information, including operative reports, are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/+4
• 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: 7895146
• Report Number: 0002249697-2018-02982
• Device Sequence Number: 2366168
• Product Code: JDI
• UDI-Device Identifier: 04546540608536
• UDI-Public: 04546540608536
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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): 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 6570-0-232
• Device Lot Number: 65417603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: Other
• Patient Age: 50 YR