MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-128
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The clinic reported the following event : "implantation failure.They couldn't have impacted.".
Event or Problem Description
The clinic reported the following event : "implantation failure.They couldn't have impacted.".
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a ceramic head was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis inspection indicated "metal transfer markings observed on head and taper consistent with attempted assembly with stem.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined." -medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the event nor the exact cause could be confirmed because insufficient information was provided.A material analysis inspection indicated "metal transfer markings observed on head and taper consistent with attempted assembly with stem.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined." if further information becomes available this investigation will be re-opened.

• Brand Name: DELTA V-40 CERAMIC HEAD 28/0
• 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: 8222762
• Report Number: 0002249697-2019-00059
• Device Sequence Number: 19250012
• Product Code: JDI
• UDI-Device Identifier: 04546540608499
• UDI-Public: 04546540608499
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 09/30/2023
• Device Catalogue Number: 6570-0-128
• Device Lot Number: 68013004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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