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	6570-0-236
Medical Device Problem Codes	Crack (1135); Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a primary implant of patient's right hip, surgeon implanted a biolox head whereupon the pa noticed black lines around the rim of the head.Surgeon could not determine if the marks were cracks or friction marks and elected to not use the implant.The head was removed and another head, which was immediately available from a loaner kit, was implanted instead.Rep reported that there was no surgical delay and no harm to the patient.
Additional Manufacturer Narrative
An event regarding the appearance of a ceramic head was reported.The event was confirmed following review of supplied photographs.Method & results: device evaluation and results: visual inspection: visual inspection was carried out on the supplied photograph.No part was returned.Marks were noted on the top and inside the tape of the head, these marks look like metal transfer marks from attempted implantation, but nothing conclusive could be determined from the photographs.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: the exact cause of the event could not be determined because insufficient was provided.Further information such as return of device is needed to complete the investigation for determining root cause.No further investigation is possible at this time.
Event or Problem Description
It was reported that during a primary implant of patient's right hip, surgeon implanted a biolox head whereupon the pa noticed black lines around the rim of the head.Surgeon could not determine if the marks were cracks or friction marks and elected to not use the implant.The head was removed and another head, which was immediately available from a loaner kit, was implanted instead.Rep reported that there was no surgical delay and no harm to the patient.

• 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: 7006536
• Report Number: 0002249697-2017-03223
• Device Sequence Number: 1750126
• Product Code: LZO
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• 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): 01/10/2018

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: 07/18/2022
• Device Catalogue Number: 6570-0-236
• Device Lot Number: 60527402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: 64 YR