MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,

Model Number 71306616

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).

Event Description

It was reported that, 3 moths after a left revision surgery performed in (b)(6) 2015 (captured under (b)(4)), the patient experienced pain on the area.The physician diagnosed traumatic bursitis, which was treated with some physical therapy and ultrasound treatment.No other complications were reported.

Manufacturer Narrative

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 reported post-revision pain is associated with the patient¿s bursitis and/or implant size and is not associated with a malperformance of the implant but is likely due to the ¿large pin¿ as reported.The patient impact cannot be determined.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 or patient reaction.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.Additional information: d3.

• Brand Name: SYN POR FEM COMP SZ 16
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11949395
• MDR Text Key: 254598138
• Report Number: 1020279-2021-05031
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010194503
• UDI-Public: 03596010194503
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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: 71306616
• Device Catalogue Number: 71306616
• Device Lot Number: 14JM06316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: R3 0 DEG XLPE ACET LNR 36MM X 52MM, LOT 13FM00576; R3 0 DEG XLPE ACET LNR 36MM X 52MM, LOT 13FM00576; R3 3 HOLE ACET SHELL 52MM, LOT NUMBER 13HM02361; REF INTERFIT THRD HOLE COVER, LOT 13HM178787; REF INTERFIT THRD HOLE COVER, LOT 13HM178787; R3 0 DEG XLPE ACET LNR 36MM X 52MM, LOT 13FM00576; R3 0 DEG XLPE ACET LNR 36MM X 52MM, LOT 13FM00576; R3 3 HOLE ACET SHELL 52MM, LOT NUMBER 13HM02361; REF INTERFIT THRD HOLE COVER, LOT 13HM178787; REF INTERFIT THRD HOLE COVER, LOT 13HM178787
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR