MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS HA CUP; HIP COMPONENT

Model Number 38HA4652

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris.Revision njr number: (b)(4), side: r, primary asa: p1 - fit and healthy.Products not revised: 1-productid: pha00240, profemur® z femoral stem size 5 cementless, lot number: ni, qty: 1.2-productid: pha01202, profemur® neck neutral short, lot number: ni, qty: 1.

Manufacturer Narrative

Due to human error the document was not attach in the previous report.

Event Description

Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris revision njr number: 4914788 side:r primary asa: p1 - fit and healthy products not revised: 1-productid: pha00240, profemur® z femoral stem size 5 cementless, lot number: 058595929, qty: 1.2-productid: pha01202, profemur® neck neutral short, lot number: 048583129, qty: 1.Additional information received on 9/15/2022: it was stated from uk njr that this looks to be a same day bilateral so there are two sets of implants.However, one set of implants regarding primaryprocedureid # 612754 has an unrevised status.Review of initial documentation provided from njr (excel document) confirms that the set of implants regarding primaryprocedureid # 612754 are not revised.Excel document shows no alleged complaint against the unrevised implants.Unrevised products for primaryprocedureid # 612754 are: 1-productid: pha00240, profemur® z femoral stem size 5 cementless, lot number: 058608693, qty: 1.2-productid: pha01232, profemur® modular femoral neck, lot number: 048577534, qty: 1 3-productid: 38ha4652, conserve® thin shell ha coated 46mm id 52mm od beaded, lot number: 018480873, qty: 1.4-productid: 38014600, conserve® bfh® head 44mm medium neck, lot number: 068605243, qty: 1.

Manufacturer Narrative

Sectio b.5: additional information in description / section d.4: lot# added/ section f.6: awareness date has been updated.

• Brand Name: CONSERVE® PLUS HA CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15364764
• MDR Text Key: 299331198
• Report Number: 3010536692-2022-00317
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

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?: No
• Device Operator: Other
• Device Model Number: 38HA4652
• Device Catalogue Number: 38HA4652
• Device Lot Number: 018480873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2022
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/18/2022; 08/18/2022
• Supplement Dates FDA Received: 09/06/2022; 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention