MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-132
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted on into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
The customer posted a notice on their 'bulletin notice board' that the biolox delta ceramic head had a foreign body / black speck on the foamy packaging.Another device was used to complete the case.
Additional Manufacturer Narrative
An event regarding foreign matter involving a ceramic head was reported.The event was confirmed following visual inspection.Conclusions: the cause of the event was determined to be a manufacturing issue.Nc has been opened to further investigate the issue.The presence of foreign material was a result of a failed inspection as per the requirements and did not meet specification.Procedure for evaluation of the integrity of sterile barrier system seals.
Event or Problem Description
The customer posted a notice on their 'bulletin notice board' that the biolox delta ceramic head had a foreign body / black speck on the foamy packaging.Another device was used to complete the case.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/0
• 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: 7444516
• Report Number: 0002249697-2018-01177
• Device Sequence Number: 1976876
• Product Code: JDI
• UDI-Device Identifier: 04546540608505
• UDI-Public: 04546540608505
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 06/30/2022
• Device Catalogue Number: 6570-0-132
• Device Lot Number: 60075101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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