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

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

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 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 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7895146
• MDR Text Key: 120976512
• Report Number: 0002249697-2018-02982
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540608536
• UDI-Public: 04546540608536
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR