MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 3 NON-CEMENTED; PRSTHSS,HIP,HEMI,FEMORAL,METAL/POLYMER,CMNTD OR UNCMNTD

Model Number	75002699
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient suffered the breakage of the sl-plus standard stem 3 non-cemented.Its is not known how long after primary procedure it happened.
Additional Manufacturer Narrative
Results of investigation: it was reported that patient suffered the breakage of the sl-plus standard stem size 3 (75002699).Its is not known how long after primary procedure it happened.The device is question, used in treatment, was not received for evaluation.A production record review showed no deviations from standard procedures.There was no further complaint reported for the batch in question.The failure is covered through our risk management file.The ifu mentions breakage as a rare side effect.A medical assessment was not possible, as no medical documentation was provided.The surgeon reported that the breakage was very atypical.Without the part, a through investigation of this fracture is not possible.Should the devices or any other information become available, this complaint will be reassessed.To date, no further actions are deemed necessary.Smith and nephew will monitor this device for further similar issues.

• Brand Name: SL-PLUS STANDARD STEM 3 NON-CEMENTED
• Common Device Name: PRSTHSS,HIP,HEMI,FEMORAL,METAL/POLYMER,CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10261770
• Report Number: 9613369-2020-00140
• Device Sequence Number: 3065390
• Product Code: KWY
• UDI-Device Identifier: 07611996078657
• UDI-Public: 07611996078657
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 11/23/2016
• Device Model Number: 75002699
• Device Catalogue Number: 75002699
• Device Lot Number: F0911396
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 07/11/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention