MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ANTHOLOGY HIP IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01101100

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

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 03/22/2011

Event Type  Injury  

Event Description

It was reported that, after tha surgery performed on (b)(6) 2010, the clinical subject experienced bruising, swelling and pain one week after discharge.The patient contacted the hospital and was told that this was normal, but the pain and swelling increased.The patient contacted a general practitioner and was diagnosed with dvt.The symptoms withdrew after one week of treatment with warfarin.

Manufacturer Narrative

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, the clinical subject developed bruising, swelling and pain one week post discharge from a right tha.Reportedly, the patient was diagnosed by her pcp with a dvt and symptoms withdrew after one week of medication therapy (warfarin).Responses to the requested clinical documentation were not provided; therefore, the reported sade could not be further assessed.Although dvts are a known post-surgical potential risk/complication, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported symptoms and medication therapy could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available the medical investigation 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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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 ANTHOLOGY HIP IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11816772
• MDR Text Key: 250350882
• Report Number: 1020279-2021-04137
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01101100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR