MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD MEMPHIS OX; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL,

Catalog Number UNKNOWN

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

Patient Problem Unequal Limb Length (4534)

Event Date 06/07/2010

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was documented on the paper that the r3 system (smith&nephew) was applied to 1 patients and underwent a revision surgery due to excessive lengthening of the left leg.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, the data presented in the aged article refers to a patient who required revision 48 hours post tha due to significant leg-length discrepancy with noted metal transfer/gouges/scratches on the femoral head and significant poly deformation upon explantation.Reportedly, analysis revealed the femoral head was damaged during reduction of the primary tha.The requested clinical documentation had not been received as of the date of this investigation, therefore further investigation could not be performed.The physician referenced in the abstract provided an analysis of all of the attached images; therefore, no further interpretation of the attached images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.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, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN FEM HEAD MEMPHIS OX
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11066287
• MDR Text Key: 223430378
• Report Number: 1020279-2020-07737
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN R3 SHELL; UNKN R3 SHELL
• Patient Outcome(s): Hospitalization; Required Intervention