MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 58MM GROUP G; HIP COMPONENT

Model Number DSPCGG58

Device Problems Material Disintegration (1177); Naturally Worn (2988)

Patient Problem Loss of Range of Motion (2032)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient was in kitchen and felt a "pop" and then the joint squeaked.X-rays indicated a suspected cracked poly liner.During revision it was seem that the poly was intact but the patient was impinging and wearing the rim of the liner and cup.Cup was revised and a biolox delta option head was implanted.Possibly patient was externally rotating excessively leading to impingement and eccentric wear.Products not revised: profemur plasma z classic femoral stem w/long neck size 7 varus 8 degree / product id: phape244 / lot number: 0798768751605863.

• Brand Name: DYNASTY PC SHELL 58MM GROUP G
• 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: 11812446
• MDR Text Key: 250234637
• Report Number: 3010536692-2021-00287
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684DSPCGG581
• UDI-Public: M684DSPCGG581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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?: No
• Device Operator: Other
• Device Model Number: DSPCGG58
• Device Catalogue Number: DSPCGG58
• Device Lot Number: 1822162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 166