MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-32D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding pain after revision involving a trident liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant concluded: "an office visit note of (b)(6) 2012 states, "x-rays bilaterally no evidence of hardware failure, doing well".When seen on (b)(6) 2013 the x-ray was unchanged and she was doing well with no pain.She was allowed to do activities as tolerated.She was seen on (b)(6) 2013 at which time the x-ray was unchanged and she was noted to be doing well.She had occasional mild trochanteric pain on the left.There is no subsequent orthopaedic follow-up to this visit.A visit of (b)(6) 2014 was for medical follow-up for hypothyroidism, rheumatoid arthritis, and osteoporosis and describes a recent onset of left hip pain.X-ray was "unremarkable".The note states, "symptoms have mostly improved.Will contact orthopaedist for follow-up".On (b)(6) 2014 a rheumatology follow-up notes the patient on methotrexate for polyarticular rheumatoid arthritis.There are no complaints referable to the hips on this visit." product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.The following devices were also listed in this report: rest ha -5 red nk 155mm strt stm 8x12mm; cat#s-2651-0812; lot# 95369101; trident hemispherical cluster 50mm; cat#502-01-50d ; lot#5123402; 6.5 cancellous bone screw 16mm; cat#2030-6516-1; lot#99553501; 6.5 cancellous bone screw 16mm; cat#2030-6516-1; lot#91197601; 6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#10068005; c-taper cocr lfit head 32mm/0; cat#06-3200; lot#mkjxkj.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusions: the investigation confirmed the pain after revision however, the root cause could not be determined.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had occasional mild trochanteric pain on the left.A visit of (b)(6) 2014 was for medical follow-up and describes a recent onset of left hip pain.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8269043
• Report Number: 0002249697-2019-00264
• Device Sequence Number: 16694014
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 623-10-32D
• Device Lot Number: MLPTR2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 45