MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 10X100MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision of an lps distal femur due to implant breakage that took place yesterday.The patient is an (b)(6) year old female.Timeline: (b)(6) 2017 - the initial fracture happened - the patient was treated conservatively until (b)(6) 2018.(b)(6) 2018 ¿ the patient received an lps distal femur replacement due to the fracture not healing and also having an arthritic knee.(b)(6) 2020 - the patient, at home, stood up to close the curtains and heard/felt a snap as the implant broke.(b)(6) 2020 ¿ knee revised with another lps distal femur and original implants retrieved for analysis.I remember supporting the initial procedure in (b)(6) 2018 and both the surgeon and i recall an issue with the cement at the time ¿ after injecting the cement into the distal femoral shaft, he struggled to get the implant in and had to scrape some cement out of the femur ¿ the surgeon thinks it is possible this jeopardized the final fixation and contributed to the failure.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Copies of x rays were received that confirmed the product breakage.It is unlikely that a potential product issue was present.No corrective action is required.Post market surveillance per sep 419.Device history lot : 717884.Device history review : no anomalies found.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Copies of x rays were received that confirmed the product breakage.It is unlikely that a potential product issue was present.No corrective action is required.Post market surveillance per sep 419.Device history lot: 717884, a device history record review was conducted by the manufacturing site.The dhr review revealed no anomalies or deviations during the review.Device history review: no anomalies found, null.

• Brand Name: LPS CEMENTED STEM 10X100MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10007135
• Report Number: 1818910-2020-11449
• Device Sequence Number: 14314816
• Product Code: JWH
• UDI-Device Identifier: 10603295079149
• UDI-Public: 10603295079149
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K003182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2020

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 Model Number: 1987-25-110
• Device Catalogue Number: 198725110
• Device Lot Number: 717884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 05/03/2021; 11/01/2021
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/09/2020; 05/12/2021; 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 12MM; SROM*NRH REPL HINGE PIN/XSM/SM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR