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

Catalog Number	6570-0-236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right hip was revised due to a broken ceramic femoral head.No cause or contributor was reported by the surgeon, but patient use of an elliptical was mentioned.The ceramic head and liner were revised.Rep confirmed that there was no damage to and no allegations against the liner.Rep provided pre-revision x-rays and a picture of the explanted head.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed by the provided photograph.Method & results: device evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted ceramic head with blood and tissue on it.The ceramic head was fragmented into six (6) pieces.Clinician review: a review of the provided medical records was deemed insufficient by a clinical consultant indicated: provided x-ray does not confirm the reported event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the provided photograph confirmed that the ceramic head was fragmented into six (6) pieces.No cause or contributor was reported.The exact cause of the event could not be determined because insufficient information was provided.Additional information including product derails, operative reports, progress notes, serial 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.
Event or Problem Description
It was reported that the patient's right hip was revised due to a broken ceramic femoral head.No cause or contributor was reported by the surgeon, but patient use of an elliptical was mentioned.The ceramic head and liner were revised.Rep confirmed that there was no damage to and no allegations against the liner.Rep provided pre-revision x-rays and a picture of the explanted head.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+5
• 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: 8582715
• Report Number: 0002249697-2019-01850
• Device Sequence Number: 296321
• Product Code: JDI
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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 Catalogue Number: 6570-0-236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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: 55 YR
• Patient Weight: 106