MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNKN01100901

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

Patient Problems Unspecified Infection (1930); Deformity/ Disfigurement (2360)

Event Date 07/07/2021

Event Type  Injury  

Event Description

It was reported that, after a thr, the patient experienced a chronic infection and an abnormal bone growth.It is unknown when implant surgery was performed.It is also unknown how this adverse event has been treated so far, so it is ongoing issue.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, after three requests, no relevant supporting clinical documentation has been provided.Therefore, without the requested clinical information a thorough medical investigation cannot be rendered, nor cause the root cause of the reported chronic infection or abnormal bone growth be determined.Based on the information provided, it is unknown how this adverse event has been treated so far, so it is ongoing issue.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.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 R3 SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12171135
• MDR Text Key: 261661412
• Report Number: 1020279-2021-05979
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/15/2021
• 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
• Treatment: UNKN FEM HEAD MEMPHIS OX; UNKN R3 LINER CERAMIC POLY; UNKN. POLARSTEM (UNKN. TYPE)
• Patient Outcome(s): Other