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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SLR INTEGR REV STEM WITH TI/HA 7 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG SLR INTEGR REV STEM WITH TI/HA 7 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED Back to Search Results
Catalog Number 75002820
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378)
Event Date 01/01/1901
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that after thr surgery had been performed, the patient experienced and infection.It is unknown if an specific intervention was performed.Patient health status is not known.
 
Manufacturer Narrative
H3, h6: it was reported that after total hip replacement surgery had been performed using a slr integr rev stem with ti/ha 7 non-cem, the patient experienced and infection.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A review of the production documentation, including the sterilization certificate, did not detect any deviation that could have contributed to the reported failure mode.Hence there is no indication that the device was outside of specification when released for distribution.A complaint history review was performed.No additional complaint for the batch in scope was reported so far.Regarding the complaint history review on family level, the occurence and severity are in line with the corresponding risk file.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode and severity of the reported issue.A thorough medical investigation could not be performed due to insufficient information.To date, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.Based on the available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Possible causes for the reported infection could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor this device for similar issues.This investigation is considered closed.
 
Manufacturer Narrative
H10: it was reported that after total hip replacement surgery had been performed using a slr integr rev stem with ti/ha 7 non-cem, the patient experienced and infection.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A review of the production documentation, including the sterilization certificate, did not detect any deviation that could have contributed to the reported failure mode.Hence there is no indication that the device was outside of specification when released for distribution.A complaint history review was performed.No additional complaint for the batch in scope was reported so far.Regarding the complaint history review on family level, the occurrence and severity are in line with the corresponding risk file.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode and severity of the reported issue.A thorough medical investigation could not be performed due to insufficient information.To date, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.Based on the available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Possible causes for the reported infection could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor this device for similar issues.This investigation is considered closed.Internal complaint reference number: (b)(4).
 
Manufacturer Narrative
H10: this complaint has been reopened to investigate additional information received by the manufacturer.A supplemental mdr report will be submitted to communicate the results of this investigation.Additional information added: d4 (expiration date), d6a (implanted date added), d10 (concomitant products added), h4 (manufacturing date).Corrected data: b1, b5 (narrative updated).
 
Event Description
It was reported that after thr surgery had been performed on (b)(6) 2022, the patient experienced a delayed wound healing without any microorganism detected.This event has been treated without a revision surgery and the patient is currently attending follow-up treatment.
 
Manufacturer Narrative
Corrected data: h6 (type of investigation).According to the information received by the manufacturer and provided in our previous report, smith and nephew has determined that this event should be re-evaluated for mdr reporting.The new information states that there was not an infection involved, and any measures taken to address the delayed wound healing were not provided; therefore, it was determined that this case does not meet the threshold for reporting and it is now considered a non-reportable event.As a courtesy, please find below the results of our investigation.Results of investigation: it was reported that, after total hip replacement surgery had been performed on 22-mar-2022, the patient experienced a delayed wound healing without any microorganism detected.This event has been treated without a revision surgery and the patient is currently attending follow-up treatment.The slr-plus stem, bipolar prosthesis and ceramic ball head, all used in treatment, were not returned for investigation.A product evaluation was not possible.A review of the production documentation for each of the mentioned devices did not detect any deviation that could have contributed to the reported failure mode.A review of the historical complaints data for the devices concerned was performed, and other similar complaints have been identified for the ceramic ball head.No other similar complaints were found for the slr-plus stem and the bipolar prosthesis.A review of past corrective actions for the 3 devices involved was performed, no further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of the device labeling revealed that the instructions for use (lit.No.12.23, ed.03/21) states infection as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.There is no need for further actions.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
 
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Brand Name
SLR INTEGR REV STEM WITH TI/HA 7 NON-CEM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ  CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ   CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14192459
MDR Text Key289959008
Report Number9613369-2022-00226
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143096
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/24/2023
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 Catalogue Number75002820
Device Lot NumberG1804987
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/30/2022
Initial Date FDA Received04/25/2022
Supplement Dates Manufacturer Received05/27/2022
07/08/2022
02/17/2023
03/23/2023
Supplement Dates FDA Received06/21/2022
07/28/2022
02/28/2023
03/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PN: 75004376 / LOT: B2133110.; PN: 75007452 / LOT: B2143197.
Patient Outcome(s) Other; Hospitalization; Required Intervention;
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