MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS NT STANDARD STEM 2 NON-CEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 75001893

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Arthralgia (2355); Joint Laxity (4526)

Event Date 02/24/2009

Event Type  Injury  

Event Description

It was reported that the patient received a left hip implant and suffered from constant pain.The technical review of the documents stated a loosening of the prostheses of approximately 30 mm, no integration and consequently failure of the implant.Revision surgery was performed at (b)(6) hospital on (b)(6) 2009.

Manufacturer Narrative

Results of investigation: it was reported that a patient underwent a left hip implant and suffered from constant pain.The technical review of the documents stated a loosening of the prostheses of approximately 30 mm,no integration and consequently failure of the implant.The article number as well as the batch number of the complained device has not been made available.Furthermore, the device intended for use in treatment was not returned for investigation.Therefore, an appropriate investigation could not be conducted and the reported issue could not independently be confirmed.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The ifu (lit.No.12.23 ed 05/16) lists loosening as known possible risk factor resulting from hip arthroplasty.However, based on available information the root cause stays undetermined.The need for corrective action is not indicated.The complaint will be reopened should the complained device or additional information be received.

Event Description

It was reported that, after a primary thr surgery had been performed on the plaintiff's left hip on (b)(6) 2007 due to coxarthrosis, the plaintiff experienced constant pain and aseptic loosening of the stem prosthesis due to osseointegration failure with a 30 mm gap between the implant's surface and the plaintiff's anatomy.A revision surgery was performed on (b)(6) 2009 to treat this adverse event.The plaintiff's outcome is unknown.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that alleged device (from the sl-plus nt stems family) has never been registered or distributed in usa.With this information it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Internal reference number: case-(b)(4).H11.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that alleged device (from the sl-plus nt stems family) has never been registered or distributed in usa.With this information it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Internal reference number: case-(b)(4).

Manufacturer Narrative

Additional info in: d, g, h results of investigation: it was reported that, after a primary thr surgery had been performed on the plaintiff's left hip on (b)(6) 2007 due to coxarthrosis, the plaintiff experienced constant pain and aseptic loosening of the stem prosthesis due to osseointegration failure with a 30 mm gap between the implant's surface and the plaintiff's anatomy.A revision surgery was performed on (b)(6) 2009 to treat this adverse event.This complaint was reopened as additional information was received.To 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.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed two additional complaints for the batch in question.One was reported for loosening in 2010 and the second for unspecified revision in 2010.However, both investigation did not reveal any manufacturing related deviations that could have contributed to the reported issue.Additionally the device in scope was manufactured in 2005 and implanted in 2007.The long period insitu does not indicate a manufacturing related issue.A review of the risk management documentation verifies the failure mode and severity of the reported issue, which is still valid.Review of past corrective actions was performed.No further escalation is required.The ifu lists loosening as a known possible adverse effect resulting from a hip arthroplasty.A medical investigation was conducted.The provided primary operative report and chartsticks were reviewed.However, they do not aid in determining a root as they precede the reported events.Therefore, based on insufficient information, no thorough medical assessment can be performed at this time.Based on the performed investigation, the reported failure mode cannot independently be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device 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.The root cause for the reported loosening stays undetermined after investigation.Available information does not indicate the need for corrective action.The complaint will be reopened should additional information or the device be received.This device is no longer sold.

• Brand Name: SL-PLUS NT STANDARD STEM 2 NON-CEM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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 ; oberneuhofstrasse 10d; baar ; SZ
• MDR Report Key: 10538370
• MDR Text Key: 207103153
• Report Number: 9613369-2020-00178
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75001893
• Device Lot Number: A0500084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 75003903, EP-FIT SHELL, LOT: C0603273.; 75007442, BIOLOX FORTE CE BALL HEAD, LOT: B0603200.; 75007454, CERAMIC INSERT STANDARD, LOT: B0603418.; BIOLOX FORTE CE BALL HEAD 12/14 36M / 75007442.; CERAMIC CERAMIC INSERT STANDARD 44/36 / 75007454.; EP-FIT SHELL TI-PLA/SCREW OPT.50 NON-CEM / 7500390.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female