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

Catalog Number	6570-0-036
Medical Device Problem Codes	Scratched Material (3020); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
During a total hip replacement procedure, immediately after the ceramic head was secured to the neck of the femoral stem, the physician assistant observed a thin linear mark at the base of the head.The surgeon asked if it was a crack.He removed the femoral head and examined the mark.He could not determine if the mark was a fracture so he requested another femoral head.
Additional Manufacturer Narrative
An event regarding an appearance issue (possible crack/fracture) of a ceramic head was reported.Following visual inspection no crack/fracture of the ceramic head was evident but an appearance issue (scratches) was confirmed.Device evaluation and results:visual inspection: scratches were observed on the inner taper and taper rim of the ceramic head, no evidence of material integrity issues (cracks) were noted.Medical records received and evaluation: there were no medical records received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: scratches were observed on the taper rim of the ceramic head, no evidence of material integrity issues (cracks) were noted.The root cause of the scratches could not be determined.If additional information such as operative reports become available this investigation will be reopened.No further investigation is possible at this time.
Event or Problem Description
During a total hip replacement procedure, immediately after the ceramic head was secured to the neck of the femoral stem, the physician assistant observed a thin linear mark at the base of the head.The surgeon asked if it was a crack.He removed the femoral head and examined the mark.He could not determine if the mark was a fracture so he requested another femoral head.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/-5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6952450
• Report Number: 0002249697-2017-03017
• Device Sequence Number: 13730943
• Product Code: LZO
• UDI-Device Identifier: 04546540608482
• UDI-Public: 04546540608482
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 12/21/2017

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: 07/06/2022
• Device Catalogue Number: 6570-0-036
• Device Lot Number: 60431601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/21/2017
• 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: 55 YR