MAUDE Adverse Event Report: MATORTHO SAIPH KNEE; SAIPH FIXED TIBIAL BEARING BLUE LEFT SIZE E 10MM

Catalog Number	193-784
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Saiph implants were explanted on (b)(6) 2019 and were disposed of by the facility.The device history record relating to the manufacture of part 193-784 cannot be performed as the lot number of the explant was unable to be provided by the facility.It was confirmed that the reason for the required revision was due to patient ligaments becoming loose.The revision procedure was completed successfully.
Event or Problem Description
A notification was received on (b)(6) 2019."a booking was made by mr toms (consultant, (b)(6) hospital) on (b)(6) 2019 for a case on the following week ((b)(6) 2019).The booking was for a patient who required a saiph polyethylene exchange.(b)(6) (surgical practitioner, (b)(6)) provided matortho with the saiph components that the patient had in-situ to enable the correct size polyethylene inserts to be sent for the case (size e - blue).On arrival at (b)(6) hospital on (b)(6) 2019, i checked the implants and discovered that a set of green e inserts had mistakenly been sent.As such the case could not go ahead and had to be cancelled".Matortho reference: (b)(4).
Additional Manufacturer Narrative
Saiph implants were explanted on (b)(6) and were disposed of by the facility.The device history record relating to the manufacture of part 193-784 cannot be performed as the lot number of the explant was unable to be provided by the facility.It was confirmed that the reason for the required revision was due to patient ligaments becoming loose.The revision procedure was completed successfully.16apr19: additional information has been provided stating that the original surgery was performed in 2006.Also that during the revision procedure a thicker bearing did not resolve the issue and that (during the same procedure) all the matortho implants were explanted and replaced with a revision system from another company.
Event or Problem Description
A notification was received on 20feb19." a booking was made by (b)(6) on (b)(6) 2019 for a case on the following week ((b)(6) 2019).The booking was for a patient who required a saiph polyethylene exchange.(b)(6) provided matortho with the saiph components that the patient had in-situ to enable the correct size polyethylene inserts to be sent for the case (size e - blue).On arrival at (b)(6) on (b)(6) 2019, i checked the implants and discovered that a set of green e inserts had mistakenly been sent.As such the case could not go ahead and had to be cancelled." matortho reference: (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FIXED TIBIAL BEARING BLUE LEFT SIZE E 10MM
• Manufacturer (Section D): MATORTHO; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 8432903
• Report Number: 3008985661-2019-00002
• Device Sequence Number: 1634070
• Product Code: JWH
• UDI-Device Identifier: 05055455507050
• UDI-Public: 5055455507050
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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 Catalogue Number: 193-784
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: Other