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

Model Number	71338665
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11940872
• Report Number: 1020279-2021-05003
• Device Sequence Number: 4268380
• Product Code: MBL
• UDI-Device Identifier: 00885556021491
• UDI-Public: 00885556021491
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2024
• Device Model Number: 71338665
• Device Catalogue Number: 71338665
• Device Lot Number: 14MM00605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR