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

Catalog Number	6570-0-436
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Rep reported receiving the device that did not match the label on the box.Rep received a c taper universal ceramic femoral head vs ceramic v40 head.Per investigator, update from sales rep indicated that this event was related to an assembly issue between the head and the stem.
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: metal transfer marks were identified on the articulating surface and taper of the ceramic head.The device was otherwise unremarkable.A dimensional inspection was performed, all features measured conformed to the required specifications.There was no evidence of a dimensional issue.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: a dimensional inspection was performed on the returned device, all features conformed to the required specifications.No further investigation is required at this time.If further relevant information becomes available this investigation will be re-opened.
Event or Problem Description
Rep reported receiving the device that did not match the label on the box.Rep received a c taper universal ceramic femoral head vs ceramic v40 head.Per investigator, update from sales rep indicated that this event was related to an assembly issue between the head and the stem.

• 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: 6256091
• Report Number: 0002249697-2017-00251
• Device Sequence Number: 1477866
• Product Code: LZO
• UDI-Device Identifier: 04546540608567
• UDI-Public: (01)04546540608567(11)160316(17)210331(10)55077402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

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: 03/31/2021
• Device Catalogue Number: 6570-0-436
• Device Lot Number: 55077402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 03/23/2017
• 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