MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS XX-SM HINGE PIN; BONE SCREWS AND PINS : KNEE PIN ASSEMBLY

Model Number	1987-15-000
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised due to dislocating hinge.Only poly and pin was revised.Doi: unknown.Dor: (b)(6) 2021.Unknown knee side.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided from medical record review indicates the patient received a revision due to posterior dislocation of the hinged insert.It is reasonable to conclude that the device reported on this medwatch did not contribute to the posterior dislocation as the pin must be removed to address the dislocation.The hinged insert component was reported on report number 1818910-2022-00941.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.

• Brand Name: LPS XX-SM HINGE PIN
• Common Device Name: BONE SCREWS AND PINS : KNEE PIN ASSEMBLY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13265903
• Report Number: 1818910-2022-00942
• Device Sequence Number: 19689037
• Product Code: JWH
• UDI-Device Identifier: 10603295078722
• UDI-Public: 10603295078722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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: 1987-15-000
• Device Catalogue Number: 198715000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS XX-SM HINGE PIN; UNK KNEE TIBIAL INSERT LPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 125 KG