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

Model Number 71335552

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

Patient Problems Ossification (1428); Pain (1994)

Event Date 09/29/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, 6 moths after a revision surgery performed on (b)(6) 2013 (covered under (b)(4)), the patient reported increasing pain.The patient was treated with physical therapy and steroid injections, with no success.Radiographic imaging revealed that the components are well fixed and that the patient had heterotrophic ossification.The physician is concerned that the lower extremity pain is coming from the patient¿s back.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 root cause for the heterotopic ossification cannot be concluded but some patients can be genetically predisposed it is a known complication of joint surgeries and is related to the procedure and not the device.The patient¿s lower back is the source of his pain and clinical symptoms per the report and is not 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 or patient condition.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,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11947641
• MDR Text Key: 254542711
• Report Number: 1020279-2021-05029
• 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: 09/07/2021

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: 09/03/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR