MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 32MM ID US CRMC LINER 50; PROSTHESIS,HIP,SEMICONST,METAL/CERAMIC,CEMENTED/UNCEMENT

Catalog Number 71338950

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 08/21/2019

Event Type  Injury  

Event Description

It was reported that the patient had to be revised for a shattered r3 ceramic liner implanted in 2012.32 +0 alumina head was also removed.Poly liner and new head were implanted.

Manufacturer Narrative

The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Although per complaint details, the shattered ceramic liner necessitated a revision, the root cause of the shattered liner could not be concluded.Patient impact beyond the reported revision could not be determined.No further medical assessment is warranted at this time.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 32MM ID US CRMC LINER 50
• Type of Device: PROSTHESIS,HIP,SEMICONST,METAL/CERAMIC,CEMENTED/UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9087781
• MDR Text Key: 159171468
• Report Number: 1020279-2019-03436
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

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: Health Professional
• Device Catalogue Number: 71338950
• Device Lot Number: 09DT30915
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 32+0 ALUMINA HEAD PART/LOT NUMBER: UNKNOWN.; 32+0 ALUMINA HEAD PART/LOT NUMBER: UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention