MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS FEM TO SLEEVE ADAPTER +5; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Model Number 1987-06-005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fall (1848); Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2021

Event Type  Injury  

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 Description

It was reported that patient has previous dates of surgery as follows: (b)(6) 2019 (primary implantation), (b)(6) 2020 (first revision), (b)(6) 2021 (poly insert revision) and (b)(6) 2021 (third revision.Hardware was placed and or exchanged on these dates.Der's were submitted each time.Patient had returned home and was doing well.Patient has a bad fall and lacerated his knee transversely.Patient was treated at another facility.After a few weeks patient was brought to the er by his daughter were patient was seen and had an open wound.Surgeon believed there was gross contamination of the joint and chose to remove all components.A new spacer was placed and depuy cement was used but it is hospital owned so do not have part or lot information.Doi: (b)(6) 2019 (primary implantation), (b)(6) 2020 (first revision), (b)(6) 2021 (poly insert revision), (b)(6) 2021 (third revision); dor: (b)(6) 2021; right knee.This report captures the event and products involved for (b)(6) 2021.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received stating that depuy synthes product was in the patient.It was removed subsequent the noted injury.They do not believe there to have been any product deficit, however after having a open would over a joint replacement, the surgeon felt it was necessary to remove.Everything was removed.

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 related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS FEM TO SLEEVE ADAPTER +5
• Type of Device: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11437160
• MDR Text Key: 238717140
• Report Number: 1818910-2021-04614
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295078494
• UDI-Public: 10603295078494
• Combination Product (y/n): N
• PMA/PMN Number: K071417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1987-06-005
• Device Catalogue Number: 198706005
• Device Lot Number: J73Y05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE REV LPS INSRT XXSM 12MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 30MM; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV DIS POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR