MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA CERAMIC INSERT 28/39G 28MM ID; UNKNOWN

Catalog Number 4930-7-039

Device Problem Crack (1135)

Patient Problem Fall (1848)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The customer reported a cracked abg ceramic liner which had to be removed.The cause of the fracture is reported to be a fall.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an abgii 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 not performed because no medical information was provided.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 similar 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.Product surveillance will continue to monitor for trends.

Event Description

The customer reported a cracked abg ceramic liner which had to be removed.The cause of the fracture is reported to be a fall.

• Brand Name: ALUMINA CERAMIC INSERT 28/39G 28MM ID
• Type of Device: UNKNOWN
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5579349
• MDR Text Key: 42746772
• Report Number: 0002249697-2016-01221
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 4930-7-039
• Device Lot Number: 50919901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention