MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA CERAMIC INSERT TYPE 28/39; HIP IMPLANT

Catalog Number 2047-2848E

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not availlable.

Event Description

During a journal article review by the clinical research (b)(4), it was discovered that the article reports seven fractures of the abc ceramic acetabular insert.

Manufacturer Narrative

Corrected data: it was determined that the country of event was (b)(6).Additional information: patient information, device information and implant/explant dates were provided.A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Event Description

During a journal article review by the clinical research project manager, it was discovered that the article reports seven fractures of the abc ceramic acetabular insert.Implant sheets were provided from the surgeon on (b)(6) 2016.The stryker ceramic liner fractured.It was used in conjunction with competitor products.The patient had a right hip revision for ceramic liner fracture.

Manufacturer Narrative

An event regarding crack/fracture involving a ceramic liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was performed and concluded "the available information is not detailed enough to establish individual failure scenario¿s or determine whether in a very small number of individual cases a different failure mode has been in action." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including 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.

Event Description

During a journal article review by the clinical research project manager, it was discovered that the article reports seven fractures of the abc ceramic acetabular insert.Implant sheets were provided from the surgeon on (b)(6) 2016.The stryker ceramic liner fractured.It was used in conjunction with competitor products.The patient had a right hip revision for ceramic liner fracture.

• Brand Name: ALUMINA CERAMIC INSERT TYPE 28/39
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5384179
• MDR Text Key: 36586036
• Report Number: 0002249697-2016-00171
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2009
• Device Catalogue Number: 2047-2848E
• Device Lot Number: 10220602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/06/2016; 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 76