MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338665

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

Patient Problems Ossification (1428); Pain (1994)

Event Date 09/19/2016

Event Type  Injury  

Event Description

''us legal mdl'': it was reported that, after 3 moths of a revision surgery performed on (b)(6) 2016 (covered under (b)(4)), the patient experienced pain.Clinical exams revealed right hip heterotopic ossification.Hip aspiration test was performed and came negative for infection.The event was treated with injections, anti-inflammatory treatment, and physical therapy.The patient outcome is stable.No other complications were reported.

Manufacturer Narrative

A2, a3: patient information available.G3, h2,h3 and h6: given the nature of the allegation, the device, used in treatment, was not returned for evaluation.A relationship, if any, between the device and the reported incidents could not be corroborated.The clinical / medical investigation concluded that, the post revision pain is associated with her heterotopic ossification.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.It is noted patient was doing well, with no complaints of right hip pain.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 or patient reaction.Based on this investigation, the need for corrective action is not indicated.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 MULTI HOLE ACETABULAR SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11940872
• MDR Text Key: 254329164
• Report Number: 1020279-2021-05003
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021491
• UDI-Public: 00885556021491
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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: 71338665
• Device Catalogue Number: 71338665
• Device Lot Number: 14MM00605
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR