MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/

Model Number UNKN R3 CERAMIC LINER

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

Patient Problems Ossification (1428); Pain (1994)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had a primary surgery on (b)(6) 2017 where it were implanted a r3 cup, the liner and the stem.After, the patient had a first revision surgery on (b)(6).Then it was reported that another revision surgery ((b)(6) 2020) was performed because the patient presented heterotrophic ossification and pain.The surgeon has removed the stem via removal technique and replaced it with biomet/zimmer arcos stem.Also, the surgeon replaced the liner.The r3 cup was not removed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the images were reviewed, and the heterotopic ossification was confirmed.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the first revision (b)(4) could not be concluded.The 2nd revision was reportedly due to pain and heterotopic ossification, which is supported by the x-ray image (b)(4).The patient impact beyond the reported pain, ossification and two revisions, could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11143112
• MDR Text Key: 225994274
• Report Number: 1020279-2021-00225
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKN R3 CERAMIC LINER
• Device Catalogue Number: UNKN01100902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention