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-32F

Device Problems Degraded (1153); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/26/2015

Event Type  Injury  

Event Description

The surgeon reported that he undertook revision surgery in a patient who had allegedly been implanted approximately 5 or 6 years ago with a stryker 28mm ceramic head with a 32mm ceramic liner.The primary surgery was undertaken by a different surgeon.Details of the original surgery, the devices used and the revision surgery (an approximate date is given for this above) were not available on intake.The surgeon undertaking the revision is now aware that incompatible devices had allegedly been implanted and as such was not making a complaint about the product.He has queried whether increased wear of the ceramic would occur in such cases and for an indication of wear rate.Update: the customer has reported that the date of primary surgery was (b)(6) 2008.The revision was (b)(6) 2015.Presenting symptoms clunking and a feeling of instability.The customer also reported that there was no sign whatsoever of any tissue reaction at time of surgery.

Manufacturer Narrative

The catalog number and lot code were not reported.The device was reported as an unknown 32mm ceramic liner trident.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

Wear of the liner was confirmed from the material analysis review.Visual inspection revealed material damage, consistent with damage from explantation, was observed on the distal rim exterior of the sleeve.A wear scar was observed on the articulating surface of the insert.A material analysis was performed and concluded that a 32mm ceramic insert was used with a 28 mm v40 head, constituting an off-label use of the components.No data is available to assess potential wear degradation in this case.No material or manufacturing defects were observed on the device features examined.The surgeon undertaking the revision is now aware that incompatible devices had allegedly been implanted.Device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated there have been no other similar events for the reported lot.

Event Description

The surgeon reported that he undertook revision surgery in a patient who had allegedly been implanted approximately 5 or 6 years ago with a stryker 28mm ceramic head with a 32mm ceramic liner.The primary surgery was undertaken by a different surgeon.Details of the original surgery, the devices used and the revision surgery (an approximate date is given for this above) were not available on intake.The surgeon undertaking the revision is now aware that incompatible devices had allegedly been implanted and as such was not making a complaint about the product.He has queried whether increased wear of the ceramic would occur in such cases and for an indication of wear rate.Update the customer has reported that the date of primary surgery was (b)(6) 2008.The revision was (b)(6) 2015.Presenting symptoms clunking and a feeling of instability.The customer also reported that there was no sign whatsoever of any tissue reaction at time of surgery.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 4843908
• MDR Text Key: 5936671
• Report Number: 0002249697-2015-01927
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 26630302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2008
• 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