MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. SL MIA MOD.NECK F.DETACH.RASP STD 1-6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	75004604
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before surgery, while the nurses were checking the devices, a brown substance was found between components.The operation was cancelled however the patient was under anesthesia.
Additional Manufacturer Narrative
It was reported that before the surgery, while the nurses were checking the devices, a brown substance was found between components.The operation was cancelled however the patient was under anesthesia.The part (sl mia modular neck for detachable rasp, std 1-6 (75004604)) was cleaned afterwards and reused.Therefore the modular neck was not returned for investigation.A complaint history review revealed no complaints due to contamination for this part number.A production documentation review could not be performed as there was no batch number communicated.As no part was returned a visual evaluation or further analysis could not be performed.Although the surgery was cancelled while the patient was already under anesthesia, no medical documents were received.The instrument family has passed the required tests regarding the cleaning procedure.The procedure is explained in the information for use.The probable root cause of the contamination is attributed to a user error as the trial neck in scope could be reused after repeating the cleaning process.If more information regarding the batch number or the medical documentation becomes available the complaint will be reopened.As of now, no further actions can be initiated.Smith and nephew monitors the device for similar complaints.

• Brand Name: SL MIA MOD.NECK F.DETACH.RASP STD 1-6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 8840006
• Report Number: 9613369-2019-00052
• Device Sequence Number: 372206
• Product Code: JDI
• UDI-Device Identifier: 07611996085358
• UDI-Public: 07611996085358
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123598
• 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): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 75004604
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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: Hospitalization; Required Intervention