MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS FEM TO SLEEVE ADAPTER +10; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Model Number	1987-06-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was revised to address loosening of the femoral and tibia sleeves at the bone to implant interface.Depuy cement was used.The surgeon performed one stage revision as patient aspiration grew out (b)(6).All components removed and replaced.Cement was owned by hospital so no information was available in our records.Doi: (b)(6) 2020, dor: (b)(6) 2020, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: LPS FEM TO SLEEVE ADAPTER +10
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10522635
• Report Number: 1818910-2020-19889
• Device Sequence Number: 3118719
• Product Code: JWH
• UDI-Device Identifier: 10603295078500
• UDI-Public: 10603295078500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1987-06-010
• Device Catalogue Number: 198706010
• Device Lot Number: J66J31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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: ATTUNE REV LPS INSRT XXSM 14MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; CONTROL CABLE W/CABLE SLEEVE; DEPUY CEMENT; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +10; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNIVERSAL FEM SLV FUL POR 40MM; UNIVERSAL STEM 75X18MM FLUTED; ATTUNE REV LPS INSRT XXSM 14 MM; ATUN TIB SLV M/L 29 MM HALF POR; ATUNE PRESSFIT STR STEM16X60 MM; ATUNE REV RP TIB BASE SZ 4 CEM; CONTROL CABLE W/CABLE SLEEVE; DEPUY CEMENT; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +10; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNIVERSAL FEM SLV FUL POR 40 MM; UNIVERSAL STEM 75X18 MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 92