MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-44F

Device Problems Material Too Rigid or Stiff (1544); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 02/13/2015

Event Type  Injury  

Event Description

Soon after the surgery, i began experiencing discomfort in the joint area, feeling as though i had not had the re­placement at all.The sensitivity in that area felt like "bone on bone".This has persisted until now, being more prominent in the past 2 years.( i take a lot of aleve) this discomfort occurs any time i am lying on my back, i can get relief when i raise my knee in an upward position or when i am in bed the aching begins i have to raise my knee upward or in an outward position.While standing, perhaps talking to someone, i feel the aching and throbbing beginning i find i need to sit for a few minutes, when i walk away i experience stiffness until i take a few steps, but the aching persists.When i enter my car, i find it necessary to lift my right leg with my hand to help in the upward movement and balance.It really feels like my "worn-out" hip surgery.

Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat.No.: 540-11-54f, trident psl ha solid back 54mm, lot code: 29933401.Cat.No.: 6021-4535 accolade (127 deg) size 4.5 accolade (127 deg) size 4.5, lot code: 3203501.Cat.No.: 6260-9-044 v40 cocr lfit head 44mm/-4, lot code: mhe15m.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device currently implanted.

Manufacturer Narrative

An event regarding pain involving a trident liner was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned for analysis.Medical records received and evaluation: a review of the provided information by a clinical consultant could confirm "pain" from the medical records received but could not determine a root cause.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: 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.Further information such as device return, bone scan and infection work up would be helpful in investigating this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Soon after the surgery, i began experiencing discomfort in the joint area, feeling as though i had not had the replacement at all.The sensitivity in that area felt like "bone on bone".This has persisted until now, being more prominent in the past 2 years.( i take a lot of aleve) this discomfort occurs any time i am lying on my back, i can get relief when i raise my knee in an upward position or when i am in bed the aching begins i have to raise my knee upward or in an outward position.While standing, perhaps talking to someone, i feel the aching and throbbing beginning i find i need to sit for a few minutes, when i walk away i experience stiffness until i take a few steps, but the aching persists.When i enter my car, i find it necessary to lift my right leg with my hand to help in the upward movement and balance.It really feels like my "worn-out" hip surgery.

Manufacturer Narrative

Additional information: weight, weight units; outcomes attributed to ae; date of explant.An event regarding pain involving a trident liner was reported.The event was confirmed.Method & results: device evaluation and results: the device was not returned for analysis.Medical records received and evaluation: a review of the provided information by a clinical consultant could confirm "pain" from the medical records received but could not determine a root cause.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: a medical review concluded: there is no evidence of radiographically of any pathology in the right total hip arthroplasty as noted on serial x-rays for four and a half year post-operatively.Comparing the larger uncemented, rigid femoral component on the right to the cemented stem on the left, it is possible more bone remodeling on the right causing periosteal pain could be the explanation of the symptoms on the right hip.The exact cause of the event could not be determined, further information like return of device, bone scans and pathology reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Soon after the surgery, i began experiencing discomfort in the joint area, feeling as though i had not had the re­placement at all.The sensitivity in that area felt like "bone on bone".This has persisted until now, being more prominent in the past 2 years.( i take a lot of aleve) this discomfort occurs any time i am lying on my back, i can get relief when i raise my knee in an upward position or when i am in bed the aching begins i have to raise my knee upward or in an outward position.While standing, perhaps talking to someone, i feel the aching and throbbing beginning i find i need to sit for a few minutes, when i walk away i experience stiffness until i take a few steps, but the aching persists.When i enter my car, i find it necessary to lift my right leg with my hand to help in the upward movement and balance.It really feels like my "worn-out" hip surgery.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4591844
• MDR Text Key: 5448126
• Report Number: 0002249697-2015-00690
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

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: 05/31/2014
• Device Catalogue Number: 623-00-44F
• Device Lot Number: MHJK3Y
• Other Device ID Number: STERILE LOT# MSGHJ27E4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2015
• Initial Date FDA Received: 03/11/2015
• Supplement Dates Manufacturer Received: Not provided; 11/10/2017
• Supplement Dates FDA Received: 07/29/2015; 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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: 74 YR
• Patient Weight: 83