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

Catalog Number	6570-0-032
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The ceramic head broke spontaneously after being placed on the stem, even before the hip was reshaped.The procedure was finished successfully with replacement of the broken item.
Additional Manufacturer Narrative
Reported event: an event regarding a fractured ceramic head during attempted assembly was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), images of the device are included in the mar.The mar indicated: the ceramic head was fractured with two (2) fragments returned for analysis, comprising approximately 100% of the head.Examination of the region on the two fragments that make up the portion of the female head taper revealed a circumferential metallic band pattern.This is consistent with the condition that the trunnion was properly seated in the taper.Macro-features of the fracture illustrate the approximate fracture origin and indicated hoop stresses that were consistent with an overload event.The mar concluded: "there was no evidence of manufacturing or material defects observed on the returned ceramic head.Examination of the female taper fragments indicated a condition consistent with a properly seated trunnion in the taper.Macro-features of the fracture indicated hoop stresses that were consistent with an overload event.The approximate fracture origin is located adjacent to the proximal taper undercut." -medical records received and evaluation: no medical information was received and no adverse consequences to the patient were reported.-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: a material analysis was performed and concluded "there was no evidence of manufacturing or material defects observed on the returned ceramic head" the exact cause of the event was determined to be as a result of an overload event as indicated by the mar.No further investigation is required at this time.Product surveillance will continue to monitor for trends.
Event or Problem Description
The ceramic head broke spontaneously after being placed on the stem, even before the hip was reshaped.The procedure was finished successfully with replacement of the broken item.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/-4
• 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: 6369971
• Report Number: 0002249697-2017-00719
• Device Sequence Number: 34191
• Product Code: LZO
• UDI-Device Identifier: 04546540608475
• UDI-Public: (01)04546540608475(11)160905(17)210930(10)57059302
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 09/30/2021
• Device Catalogue Number: 6570-0-032
• Device Lot Number: 57059302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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