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

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.

• 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 Key: 14192459
• MDR Text Key: 289959008
• Report Number: 9613369-2022-00226
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143096
• Number of Events Reported: 1
• 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 Number: 75002820
• Device Lot Number: G1804987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/27/2022; 07/08/2022; 02/17/2023; 03/23/2023
• Supplement Dates FDA Received: 06/21/2022; 07/28/2022; 02/28/2023; 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 75004376 / LOT: B2133110.; PN: 75007452 / LOT: B2143197.
• Patient Outcome(s): Other; Hospitalization; Required Intervention