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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed in the right hip since, upon ct scan, it was noticed that one of the pelvic screws was in the soft tissues requiring femoral head revision.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical medical team concluded, based on the available documentation, the root cause of the four right hip revisions, from the first revision, the cause was not determined, to the screw that was too long, to the infection, and then the scar tissue cannot be definitively concluded.The multiple surgeries could have contributed to the infection and the scar tissue.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The first, left hip revision was performed of pain.The second revision was done for elevated metal ion levels and the tissue character which may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.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.This again, cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints 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: 8418544
• Report Number: 1020279-2019-01060
• Device Sequence Number: 1341138
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: No Information
• Device Expiration Date: 09/12/2020
• Device Catalogue Number: 71342340
• Device Lot Number: 10BM10676A
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1