MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 0580-1-501

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient reported a primary stryker tha was implanted in her left hip (b)(6) 2022 1 day post-op, patient noticed a limb length discrepancy of approximately an additional.75" on her operative side (patient is 65" standing on her right foot, 65.75" standing on her left foot).Index surgeon proposed to implant a tha on the contralateral side to match limb lengths.After seeking a second opinion, a revision of the hip is scheduled (b)(6) 2022.Revising surgeon reported to the patient that the implants were too large for the patient's anatomy.Patient is inquiring if there have been other reports of limb length discrepancy reported with the index surgeon or with her implants.Update (b)(6) 2022 (b)(6): clarification from patient: "i'm not sure he [revising surgeon] actually said it was too big for my anatomy, more that the angle was wrong.We didn't really understand.On my last post op visit with the original doctor he changed his plan from doing my right hip to having pelvic obliquity physical therapy for my left and getting a special shoe made.".

Event Description

Patient reported a primary stryker tha was implanted in her left hip (b)(6) 2022.1 day post-op, patient noticed a limb length discrepancy of approximately an additional.75" on her operative side (patient is 65" standing on her right foot, 65.75" standing on her left foot).Index surgeon proposed to implant a tha on the contralateral side to match limb lengths.After seeking a second opinion, a revision of the hip is scheduled (b)(6) 2022.Revising surgeon reported to the patient that the implants were too large for the patient's anatomy.Patient is inquiring if there have been other reports of limb length discrepancy reported with the index surgeon or with her implants.Update: clarification from patient: "i¿m not sure he [revising surgeon] actually said it was too big for my anatomy, more that the angle was wrong.We didn¿t really understand.On my last post op visit with the original doctor he changed his plan from doing my right hip to having pelvic obliquity physical therapy for my left and getting a special shoe made." update: revision was due to leg length discrepancy and gait.Revision hip is "doing well.".

Manufacturer Narrative

An event regarding limb length discrepancy involving an unknown hip was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "the records confirm the patient had advanced osteoarthritis of the left hip and following medical clearance underwent an uneventful total hip arthroplasty on (b)(6) 2022 and was discharged the following day.No complications were noted.No postoperative records were present for review.It is confirmed the patient had a left tha performed on (b)(6) 2022.There are no records available to substantiate a post-operative leg length discrepancy, nor the need for, and completion of, a revision tha surgery." device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, primary operative report 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient reported a primary stryker tha was implanted in her left hip (b(6) 2022.1 day post-op, patient noticed a limb length discrepancy of approximately an additional.75" on her operative side (patient is 65" standing on her right foot, 65.75" standing on her left foot).Index surgeon proposed to implant a tha on the contralateral side to match limb lengths.After seeking a second opinion, a revision of the hip is scheduled (b(6) 2022.Revising surgeon reported to the patient that the implants were too large for the patient's anatomy.Patient is inquiring if there have been other reports of limb length discrepancy reported with the index surgeon or with her implants.Update: clarification from patient: "i¿m not sure he [revising surgeon] actually said it was too big for my anatomy, more that the angle was wrong.We didn¿t really understand.On my last post op visit with the original doctor he changed his plan from doing my right hip to having pelvic obliquity physical therapy for my left and getting a special shoe made." update: revision was due to leg length discrepancy and gait.Revision hip is "doing well.".

Manufacturer Narrative

Reported event: an event regarding limb length discrepancy involving a exeter stem 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 was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: the records confirm the patient had advanced osteoarthritis of the left hip and following medical clearance underwent an uneventful total hip arthroplasty on (b(6) 2022 with an exeter v40 stem and ceramic head.She was discharged the following day.No complications were noted.No postoperative records were present for review.It is confirmed the patient had a left tha performed on (b(6) 2022.There are no records available to substantiate a post-operative leg length discrepancy, nor the need for, and completion of, a revision tha surgery.-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: a review of the provided medical records by a clinical consultant indicated: the records confirm the patient had advanced osteoarthritis of the left hip and following medical clearance underwent an uneventful total hip arthroplasty on (b(6) 2022 with an exeter v40 stem and ceramic head.She was discharged the following day.No complications were noted.No postoperative records were present for review.It is confirmed the patient had a left tha performed on (b(6) 2022.There are no records available to substantiate a post-operative leg length discrepancy, nor the need for, and completion of, a revision tha surgery.The event could not be confirmed.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 50MM NO 1
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15223184
• MDR Text Key: 297859846
• Report Number: 0002249697-2022-01178
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011623
• 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,Followup
• Report Date: 05/29/2023

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 Model Number: 0580-1-501
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G8012319A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 10/14/2022; 05/03/2023
• Supplement Dates FDA Received: 11/09/2022; 05/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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): Required Intervention; Hospitalization; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG