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

Model Number	6570-0-032
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/07/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding revision due to infection involving a ceramic head was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection,functional, dimensional and material analysis of device could not performed as no device was returned for examination.Medical records evaluation: no medical reports were available for review device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot and no other similar events were reported for the sterile lot.Conclusions: the event revision due to infection involving a ceramic head was reported.The event was not confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as returned devices and more medical documentation are needed.Infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name: trident 0 deg x3 insert 32mm head; cat# : 623-00-32d ; lot#: mldwyr.Device name: 6.5 cancellous bone screw 35mm; cat#: 6570-0-032 lot#: mljpy1.Device name: unknown_50d shell; cat#: unknown; lot#: unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
In reporting a revision of the patient's right hip on (b)(6) 2020, the rep learned the patient had a revision on (b)(6) 2012 due to infection.The femoral head only was exchanged.Rep confirmed no further information will be released by the hospital or surgeon.This pi is for the (b)(6) 2012 revision.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/-4
• 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: 10533962
• Report Number: 0002249697-2020-01892
• Device Sequence Number: 2385797
• Product Code: JDI
• UDI-Device Identifier: 04546540608475
• UDI-Public: 04546540608475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 6570-0-032
• Device Catalogue Number: 6570-0-032
• Device Lot Number: 40123902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/15/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 49 YR