MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 502-11-52E

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Anemia (1706); Pain (1994); Depression (2361); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 12/13/2013

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding pain involving a trident shell was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted clinician review: a review of the provided medical records by a clinical consultant stated the following comment: based upon the information given to me and the supporting documentation i cannot confirm that this event did occur.As to the root cause of the event, this cannot be determined since i cannot discern any adverse impact on the patient related to the episode of care.X-rays and office notes would be helpful in this regard.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 11 june 2013 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes 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 to indicate further evaluation is warranted, this record will be reopened.Device evaluated by manufacturer? not available.

Event Description

2014 right hip replacement with stryker.2017 left hip replacement with stryker.Update: as per patient, she had a right tha done (b)(6) 2013 about four months after surgery she couldn't walk during pt, she started to experience pain, has no balance.Patient has to use a walker.Patient would like to know if her implants are part of a recall.Patient is seeking assistance with revision surgery.

Manufacturer Narrative

Reported event: an event regarding limb length discrepancy and instability involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted clinician review: a review of the provided medical records by a clinical consultant indicated:based upon the information given to me and the supporting documentation i cannot confirm that this event did occur.As to the root cause of the event, this cannot be determined since i cannot discern any adverse impact on the patient related to the episode of care.X-rays and office notes would be helpful in this regard.Taking into consideration all of the material subsequently submitted, it does not change my previously stated opinion.The most important information not provided are patient¿s postoperative office notes by dr.And postoperative x-rays taken with proper positioning.It is well-known that patients who have been given an increased offset following total hip replacement can experience symptoms consistent with lateral hip pain and trochanteric bursitis.I am not saying that this has happened in this case, but further documentation, notes and x-rays would be needed in order to make a final appraisal product history review: review of the device history records indicate 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 lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports as well as patient history and follow-up notes 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 to indicate further evaluation is warranted, this record will be reopened.

Event Description

2014 right hip replacement with stryker, 2017 left hip replacement with stryker.Update: as per patient, she had a right tha done (b)(6) 2013 about four months after surgery she couldn't walk during pt, she started to experience pain, has no balance.Patient has to use a walker.Patient would like to know if her implants are part of a recall.Patient is seeking assistance with revision surgery.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11378364
• MDR Text Key: 233568685
• Report Number: 0002249697-2021-00347
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540432032
• UDI-Public: 04546540432032
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: 06/30/2018
• Device Model Number: 502-11-52E
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 44106001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 82