MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-136
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that all devices in the lot were manufactured and accepted into final stock with no reported discrepancies.Lot id.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left hip was revised due to infection (infection clinically confirmed, infecting microorganism not reported to rep).A 36 +0 ceramic head and 36 0° poly liner were revised to a c-taper head and sleeve with a 36e liner.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
Event or Problem Description
It was reported that the patient's left hip was revised due to infection (infection clinically confirmed, infecting microorganism not reported to rep).A 36 +0 ceramic head and 36 0° poly liner were revised to a c-taper head and sleeve with a 36e liner.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
Additional Manufacturer Narrative
The following device was also listed in this report: trident 0° x3 insert 36mm id cat# 623-00-36e lot# mje0x3 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a ceramic head was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned/ remains implanted -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 and 4 similar events for the sterile lot.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/0
• 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: 8419933
• Report Number: 0002249697-2019-01313
• Device Sequence Number: 13522391
• Product Code: JDI
• UDI-Device Identifier: 04546540608512
• UDI-Public: 04546540608512
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 02/28/2015
• Device Catalogue Number: 6570-0-136
• Device Lot Number: 32758601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 78