MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION OFFSET STEM ADAPTER, OFFSET 4MM; SEMI-CONSTRAINED TOTAL KNEE PROSTHESES

Catalog Number	2903-3020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to our investigation including review of material certificate and production history record, all devices of the risk lot were manufactured without deviation, and inspection record revealed that all results met the acceptance criteria.There was no similar events for the same lot device has been found except this case.The product is not available to be returned for further evaluation.Current information is insufficient to permit a conclusion as to the cause of the event.If any further information becomes available, a supplemental will be filed accordingly.[(b)(4)].
Event or Problem Description
It was reported to uoc that a patient who had undergone a prior knee revision surgery, had to be revised.In the revision, the surgeon removed a broken device and implanted new revision components.

• Brand Name: OFFSET STEM ADAPTER, OFFSET 4MM
• Common Device Name: SEMI-CONSTRAINED TOTAL KNEE PROSTHESES
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave. 2,; science park, east dist.; hsinchu, 30075 ; TW 30075
• MDR Report Key: 7546985
• Report Number: 9681642-2018-00001
• Device Sequence Number: 11215855
• Product Code: JWH
• UDI-Device Identifier: 04712771509908
• UDI-Public: 04712771509908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: 08/06/2020
• Device Catalogue Number: 2903-3020
• Device Lot Number: 15H008A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/25/2018
• 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
• Patient Age: 84 YR