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

Catalog Number	623-10-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: trident psl ha solid back 50mm; cat#540-11-50e; lot#44338201.Accolade tmzf hip stem #4; cat#6020-0435; lot# 42537805.Delta v-40 ceramic head 32/0; cat#6570-0-132; lo#3560603.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Right total hip replacement on (b)(6) 2013.On (b)(6) 2014 patient reports ´pain right hip since 3 weeks´, diagnosed as ´bursitis trochanterica right side, after total hip replacement right side´.On (b)(6) 2016 patient reports that he is complaint free.
Additional Manufacturer Narrative
An event regarding pain involving a trident liner was reported.The event was confirmed trough the medical records provided.Device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: degenerative disease related muscle atrophy around the hip with contracture in the iliotibial tract has contributed to temporary overload on the hip musculature during early recovery after accolade/trident total hip arthroplasty with symptoms of trochanteric bursitis, relieved rapidly and permanently by simple conservative treatment.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion a review of the provided medical records and x-rays by a clinical consultant indicated: degenerative disease related muscle atrophy around the hip with contracture in the iliotibial tract has contributed to temporary overload on the hip musculature during early recovery after accolade/trident total hip arthroplasty with symptoms of trochanteric bursitis, relieved rapidly and permanently by simple conservative treatment.No revision surgery has been reported.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Right total hip replacement on (b)(6) 2013.On (b)(6) 2014 patient reports ´pain right hip since 3 weeks´, diagnosed as ´bursitis trochanteria right side, after total hip replacement right side´.On (b)(6) 2016 patient reports that he is complaint free.

• 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: 8091548
• Report Number: 0002249697-2018-03788
• Device Sequence Number: 1459758
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 10/31/2018
• Device Catalogue Number: 623-10-32E
• Device Lot Number: 45659201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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: 59 YR
• Patient Weight: 83