MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/-2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6570-0-436
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
Event or Problem Description
The 36mm -2.5 biolox ceramic head v40 taper didn't successfully sit onto accolade ii v40 trunnion.Surgeon unsure if soft tissue impingement caused the head to not sit properly, however decided to open and use a different femoral head.Hospital staff discarded of implant per hospital protocol.
Additional Manufacturer Narrative
An event regarding a size/fit issue involving a ceramic head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as device was not returned.Medical records received and evaluation: a medical review was not performed because no information was provided.Device history review: a review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: a 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 information was provided.Further information such as product return is needed to complete the investigation for determining a root cause.
Event or Problem Description
36mm -2.5 biolox ceramic head v40 taper didn't successfully sit onto accolade ii v40 trunnion.Surgeon unsure if soft tissue impingement caused the head to not sit properly, however decided to open and use a different femoral head.Hospital staff discarded of implant per hospital protocol.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/-2,5
• 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: 6597507
• Report Number: 0002249697-2017-01712
• Device Sequence Number: 16276937
• Product Code: LZO
• UDI-Device Identifier: 04546540608567
• UDI-Public: (01)04546540608567(11)170215(17)220215(10)58773201
• 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): 08/01/2017

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: 02/28/2022
• Device Model Number: 6570-0-436
• Device Catalogue Number: 6570-0-436
• Device Lot Number: 58773201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/01/2017
• 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