MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT

Catalog Number 625-0T-32E

Device Problems Device Slipped (1584); Noise, Audible (3273)

Patient Problems Debris, Bone Shedding (1803); Pain (1994); Disability (2371); Ambulation Difficulties (2544)

Event Date 07/06/2005

Event Type  Injury  

Event Description

"volun 31-mar-2014: total hip implant (b)(6) 2005.Had pain at first and hip felt loose.Went back to hospital several times for x-rays taking continuous meds.Hip began to pop and click and squeak.Hip becomes inflamed if stand or walk on it.On (b)(6) 2013 (b)(6) hospital (b)(6).X-ray surgeon reports that implant has caused my bone to become deformed.Said bones have grown out into muscles that the hip implant can never be removed because, the bone growth (caused by the implant) has grown into muscles on leg.Surgeon said they would ruin my leg muscle if they try to revise hip again.Hip and inability to stand or walk has disabled me.On a lot pain meds.Hurts to sit, stand or lay down.".

Manufacturer Narrative

Additional devices reported in this event are: unknown stem cat # 6565-0-132, lot # 12943801, description: alumina v40-femoral head 32mm, +0mm nk.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report.Device remains implanted.

Manufacturer Narrative

(b)(6).An event regarding audible noise involving a trident ceramic liner was reported.The event was not confirmed.-medical records received and evaluation: the provided records were rejected for review by a consulting clinician.Medical records with confirmation of event and progress notes would be required to provide a meaningful dictation for this case.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review found no other similar events have been reported for the subject manufacturing lot.Conclusions: the event could not be confirmed nor the root cause of the reported audible noise determined due to the minimal information received.

Event Description

"volun 31-mar-2014: total hip implant (b)(6) 2005.Had pain at first and hip felt loose.Went back to hospital several times for x-rays taking continuous meds.Hip began to pop and click and squeak.Hip becomes inflamed if stand or walk on it.On (b)(6) 2013 (b)(6) hospital (b)(6).X-ray surgeon reports that implant has caused my bone to become deformed.Said bones have grown out into muscles that the hip implant can never be removed because the bone growth (caused by the implant) has grown into muscles on leg.Surgeon said they would ruin my leg muscle if they try to revise hip again.Hip and inability to stand or walk has disabled me.On a lot pain meds.Hurts to sit, stand or lay down.".

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3817604
• MDR Text Key: 4400136
• Report Number: 0002249697-2014-01858
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

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: Lay User/Patient
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 11781203
• Other Device ID Number: STER. LOT 0501EIRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2005
• 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
• Patient Age: 52 YR
• Patient Weight: 118