MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Model Number 71335552

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

Patient Problems Ossification (1428); Ecchymosis (1818); Pain (1994)

Event Date 06/14/2012

Event Type  Injury  

Manufacturer Narrative

Internal reference (b)(4).

Event Description

It was reported that, after a tha performed in (b)(6) 2011, and a motorcycle accident in (b)(6) 2012, the patient experienced pain around the hip.Physician confirmed ecchymosis, however it was indicated that the hip was in good position and no intervention was performed.The patient continues to have pain, so he was treated with steroid injection and physiotherapy since 2012 due to pain, heterotrophic ossification and trochanteric bursitis.No other complication were reported.

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, the patient had a left tha (b)(6) 2011.He had a revision (b)(6) 2013, 20 months post implantation.Patient was involved in mva, (b)(6) 2012.Dr.(b)(6) noted, ¿injured low back - compression fractures, he also has ecchymosis and pain about the left hip.X-rays good condition.There has been no change in position of the hardware.Brooker ii heterotopic ossification about the left hip, excellent range of motion as evidenced by the patient's frog-leg lateral.Heterotopic bone, but this is not blocking rotation.¿ treated with celebrex, physical therapy and steroid injection into the iliopsoas tendon.On (b)(6) 2013 dr.Marwin noted, ¿ct reveals adequate osteointegration of acetabular and femoral components.The brooker ii ho is easily seen in the scans.The concerning finding in the femoral side of the joint include radiolucencies around the femoral component along the entire length of the stem and a very attenuated anterior metaphyseal cortex with an old fracture anteriorly which appears to be filled in with bone.There is no gross loosening on serial x-rays.¿ patient had a revision and intraoperatively the surgeon noted, ¿femoral component was loose.There was no gross evidence of infection plus patient's preoperative infection workup is negative.¿ the patient¿s pain may be associated with the trochanteric bursitis and/or the heterotopic ossification.The root cause of the trochanteric bursitis or the heterotopic ossification cannot be concluded; however, some patients can be genetically predisposed to heterotopic ossification.It is a known complication of joint surgeries and is related to the procedure and not the device.It cannot be concluded the trochanteric bursitis and/or the heterotopic ossification is associated with a malperformance of the implant.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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, 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: R3 3 HOLE ACET SHELL 52MM
• 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: 11947980
• MDR Text Key: 254556605
• Report Number: 1020279-2021-05030
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• 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: 08/03/2021

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 Expiration Date: 06/24/2021
• Device Model Number: 71335552
• Device Catalogue Number: 71335552
• Device Lot Number: 11FM16286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention