MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH PRI FEM COMP HO SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71341024
Medical Device Problem Codes	Biocompatibility (2886); Migration (4003)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a right mom-thr had been performed, patient experienced cobalt levels at 270 (h) and chromium levels at 31.0 (h).There was an increased subsidence of the femoral stem when compared with previous, which raised suspicion for component loosening.There were degenerative changes in lower lumber spine and at the sacroiliac joints.Sclerosis about symphysis pubis likely reflecting long-standing stress-related changes, as well as degenerative changes in the lower lumber spine and at the sacroiliac joints.Sclerosis about symphysis pubis likely reflecting long-standing stress-related changes.This adverse event was addressed by revision surgery.Patient's current health status is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events.The patient impact beyond the reported events cannot be determined with the limited information provided.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that looseness of components has been identified in adverse events section failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening which may lead to revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include alignment, size selected, procedural/user error, traumatic injury, implant corrosion, irregular implant interaction, abnormal motion over time, patient anatomy or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Dear ladies & gentleman, smith and nephew has received a notification from an external counsel indicating that the information handled through this complaint ((b)(4) / fda report number: 1020279-2022-04177) belongs to the same subject and clinical event that was captured under complaint (b)(4) (fda report numbers: 3005975929-2021-00434 and 3005975929-2021-00435).As (b)(4) was received first, smith and nephew is keeping this record and migrating all existing communications & information from (b)(4) to it before closing the later as a duplicated non-valid record.The associated investigation will be continued and the results will be submitted as part of the supplemental reports for (b)(4).

• Brand Name: ECH PRI FEM COMP HO SZ 14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15483676
• Report Number: 1020279-2022-04177
• Device Sequence Number: 19312297
• Product Code: JDI
• UDI-Device Identifier: 03596010440280
• UDI-Public: 03596010440280
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 71341024
• Device Catalogue Number: 71341024
• Device Lot Number: 07BM01858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 12/15/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 10/22/2022; 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown