UNKN JOINT REPAIR DEV
Received Jul 14, 2023 · Event occurred Dec 24, 2021
Report 1219602-2023-01224 · MDR key 17330392
Device
Generic name
Retention Device, Suture
Manufacturer
Smith & Nephew, Inc.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR · Male
- Damage to Ligament(s)
- Damage to Ligament(s)
Narrative
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: KATAGIRI, H., NAKAGAWA, Y., MIYATAKE, K., OZEKI, N., KOHNO, Y., AMEMIYA, M., ... & KOGA, H. (2021). COMPARISON OF CLINICAL OUTCOMES AFTER REVISION ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING A BONE-PATELLAR TENDON-BONE AUTOGRAFT AND THAT USING A DOUBLE-BUNDLE HAMSTRING TENDON AUTOGRAFT. THE JOURNAL OF KNEE SURGERY, 36(06), 613-621. H10: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem
IT WAS REPORTED THAT ON LITERATURE REVIEW COMPARISON OF CLINICAL OUTCOMES AFTER REVISION ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING A BONE-PATELLAR TENDON-BONE AUTOGRAFT AND THAT USING A DOUBLE-BUNDLE HAMSTRING TENDON AUTOGRAFT, 1 PATIENT FROM THE HT GROUP HAD A GRAFT RERUPTURE 110 MONTHS AFTER AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE USING A XTENDOBUTTON. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.