MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71342340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had recurrent right hip dislocations on (b)(6) 2018 and (b)(6) 2018.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the revision pathology: ¿ ¿right hip scar and synovium, excision: scarred, inflamed and reactive synovium, with hemorrhage and changes consistent with the patient's history.No distinct histologic evidence of alval.There is a small amount of corrosion noted on the trunnion.Although there is corrosion of the trunnion and black viscous joint fluid consistent with findings associated with trunnionosis, the root cause cannot be determined nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.The impact beyond the revision cannot be determined.It was reported also that patient had recurrent dislocations 3 months post revision of right hip twice within a two week period.Patient slipped on the mud and fell from a standing position 12 days later.Closed reduction was performed in the ed both times.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: 40MM OXINIUM MODULAR HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8636120
• Report Number: 1020279-2019-02034
• Device Sequence Number: 1858352
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71342340
• Device Lot Number: 17EM01560
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR