MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STEM LATERAL 2 NON-CEMENTED; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75002750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery, there were high levels of metals found in the blood of the patient.A revision surgery was performed on (b)(6) 2021 to treat this event.The sl-plus stem lateral 2 non-cemented case (b)(4) and the oxinium fem hd 12/14 32mm +8 case (b)(4) were explanted.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after thr surgery, there were high levels of metals found in the blood of the patient.A revision surgery was performed to treat this event.The sl-plus stem lateral 2 non-cemented and the oxinium fem hd 12/14 32mm +8 were explanted.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted, and the reported failure mode could not independently be confirmed.The batch number of this device was not communicated and a review of the batch record could not be conducted.A complaint history review was performed.A medical investigation was conducted.With the information provided the clinical root cause of the reported ¿high levels of metals in the blood¿ and metallotic synovitis cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met 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.No probable cause can be determined.The need for corrective action is not indicated.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.
Additional Manufacturer Narrative
H3, h6: it was reported that after thr surgery, there were high levels of metals found in the blood of the patient.A revision surgery was performed to treat this event.The sl-plus stem lateral 2 non-cemented and the oxinium fem hd 12/14 32mm +8 were explanted.The devices used in treatment were returned for investigation.A visual inspection and material analysis were conducted.Heavy scratch marks from an abrasive tool as well as screw holes on the lateral side were observed on the complained device.The alignment of the 11 screw holes in a single line indicates that they most probably originated from the fixation of a trauma implant.However, according to the complainant there was no additional surgery between the initial implantation of the prothesis and the revision.The origin of the observed scratch marks and lateral screw holes stays therefore undetermined.It is however assumed that the observed damage on the stem was caused while in situ with the patient.Abrasive residues from drilling are not ruled out to have contributed to the reported high levels of metals found in the blood of the patient.A medical investigation was conducted.With the information provided the clinical root cause of the reported ¿high levels of metals in the blood¿ and metallotic synovitis cannot be confirmed.However, the noted mechanical damage to the femoral stem cannot be ruled out as a contributing factor.It cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.The device labeling is placed on the front end of the taper.The ball heat is still seated on the taper and the batch number could not be accessed.A review of the batch record and batch specific complaint history review could therefore not be conducted.However, a review of the complaint history revealed no additional complaint with similar issues for the device in scope (75002750).The ifu (lit.No.12.23 ed 05/16) list the reported issue as known possible side effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the performed investigations, mechanical damage on the stem was confirmed.The relationship between the high level of metals found in the blood of the patient and the observed mechanical damage cannot be excluded.The conducted investigation does not indicate that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the observed mechanical damage is attributed to an unintended use error that caused or contributed to the event.The conducted investigation does not indicate the need for corrective action.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The returned devices will be retained.
Additional Manufacturer Narrative
Results of investigation: it was reported that after thr surgery, there were high levels of metals found in the blood of the patient.A revision surgery was performed to treat this event.The sl-plus stem lateral 2 non-cemented and the oxinium fem.Hd 12/14 32mm +8 were explanted.The devices used in treatment were returned for investigation.A visual inspection and material analysis were conducted.Heavy scratch marks from an abrasive tool as well as screw holes on the lateral side were observed on the complained device.The alignment of the 11 screw holes in a single line indicates that they most probably originated from the fixation of a trauma implant.However, according to the complainant there was no additional surgery between the initial implantation of the prothesis and the revision.The origin of the observed scratch marks and lateral screw holes stays therefore undetermined.It is however assumed that the observed damage on the stem was caused while in situ with the patient.Abrasive residues from drilling are not ruled out to have contributed to the reported high levels of metals found in the blood of the patient.A medical investigation was conducted.With the information provided the clinical root cause of the reported ¿high levels of metals in the blood¿ and metallotic synovitis cannot be confirmed.However, the noted mechanical damage to the femoral stem cannot be ruled out as a contributing factor.It cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported event.A review of the complaint history revealed no additional complaint for the batch in question nor similar issues for the device in scope (75002750).The ifu (lit.No.12.23 ed 05/16) list the reported issue as known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the performed investigations, mechanical damage on the stem was confirmed.The relationship between the high level of metals found in the blood of the patient and the observed mechanical damage cannot be excluded.The conducted investigation does not indicate that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the observed mechanical damage is attributed to an unintended use error that caused or contributed to the event.The conducted investigation does not indicate the need for corrective action.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The device was returned to the customer.

• Brand Name: SL-PLUS STEM LATERAL 2 NON-CEMENTED
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• 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: 11891042
• Report Number: 9613369-2021-00268
• Device Sequence Number: 19741107
• Product Code: LZO
• UDI-Device Identifier: 07611996078022
• UDI-Public: 07611996078022
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2016
• Device Model Number: 75002750
• Device Catalogue Number: 75002750
• Device Lot Number: C0907917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 10/26/2021; 10/26/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/09/2021; 10/27/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2009
• 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; Other
• Patient Age: 52 YR
• Patient Sex: Male