MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	625-0T-32E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Device not returned.
Event or Problem Description
A (b)(6)-year-old patient, hospitalized for a revision of a prosthesis of bipolar right hip following a fall at home in (b)(6) 2018.In (b)(6), the patient consults for severe pain.We radiologically detects a fracture of the ceramic insert at the level of the right acetabulum.This was a 2009 hip replacement.This pi is for the breakage of the insert.The other devices used were not stryker devices.The patient underwent surgery for bipolar revision of his hip prosthesis: total hip revision.In 2009, it was also a total hip recovery.
Event or Problem Description
76-year-old patient, hospitalized for a revision of a prosthesis of bipolar right hip following a fall at home in (b)(6) 2018.In (b)(6), the patient consults for severe pain.We radiologically detects a fracture of the ceramic insert at the level of the right acetabulum.This was a 2009 hip replacement.This pi is for the breakage of the insert.The other devices used were not stryker devices.The patient underwent surgery for bipolar revision of his hip prosthesis: total hip revision.In 2009, it was also a total hip recovery.
Additional Manufacturer Narrative
Corrected lot number of the device.An event regarding crack/fracture and wear involving a trident alumina insert was reported.The wear of the titanium sleeve of the insert was confirmed based on the returned device, however, crack/fracture of the ceramic insert could not be confirmed as this part of the product was not returned.Method & results: device evaluation and results: analysis of the returned product indicated: damage and material loss were observed on the titanium sleeve.This is likely due to cyclic contact against the ceramic head.Debris was observed on the proximal surface surface of the insert.A sample of the debris was placed on a sem stub for further analysis.Eds (energy-dispersive spectroscopy) showed the shell and sleeve were consistent with ti-6al-4v alloy and the samples of debris were consistent with the shell and sleeve base alloys and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The ceramic insert of the alumina insert was not returned for analysis.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: material analysis completed on the retuned components confirms the wear on the titanium sleeve.The ceramic insert of the alumina insert was not returned for analysis.The mar indicates the damage observed on the sleeve is likely due to cyclic contact against the ceramic head.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The reported event indicates that the patient sustained a fall 3 months prior to the revision surgery and that a fracture of the ceramic liner was observed on x-ray, however, this fractured alumina insert could not be confirmed and the exact cause of the wear on the titanium sleeve could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays, return of the alumina insert are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8235113
• Report Number: 0002249697-2019-00144
• Device Sequence Number: 13507081
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000013
• 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): 04/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 15249502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/10/2019
• 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