MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS INTERCALARY SEGMENT 55MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number	1987-09-055
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2021
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
It was reported that the patient had a spacer made of lps implant to treat chronic infection.Segments disassociated and patient was brought to operating room.A through i&d was performed.Segments were dried and impacted together.Many attempt to separate the segments were performed with no move to at any junction.Antibiotic beads were placed and patient was closed uneventfully.The disassociation occurred between the listed segments.Doi: (b)(6) 2021.Dor: (b)(6) 2021; right knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Evaluation of all available x-rays confirmed, that the devices have been disassociated.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS INTERCALARY SEGMENT 55MM
• Common Device Name: LPS AND S-ROM : KNEE ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12330653
• Report Number: 1818910-2021-17954
• Device Sequence Number: 4713232
• Product Code: JWH
• UDI-Device Identifier: 10603295078616
• UDI-Public: 10603295078616
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 1987-09-055
• Device Catalogue Number: 198709055
• Device Lot Number: J94W33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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 INTERCALARY SEGMENT 55MM; LPS SEGMENTAL COMPONENT 85MM; LPS INTERCALARY SEGMENT 55MM; LPS SEGMENTAL COMPONENT 85MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 81