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	05/22/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient on (b)(6) 2013 due to implant failure.Femoral head was explanted.No complications reported.Related to events in mdr 3005975929-2018-00219 and mdr 3005975929-2018-00267.
Event or Problem Description
It was reported that a revision surgery was performed on the patient due a failure of the competitor acetabular component.Competitor device presented loosening.The smith&nephew femoral head and sleeve were removed.No complications reported.
Additional Manufacturer Narrative
Event,concomitant medical products, and if follow-up, what type contain additional information.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that the root cause for the first revision cannot be determined.It is unknown if early weight bearing or the patient¿s body habitus with a bmi of 32.36 contributed to the problem.The second revision¿s clinical information may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It is noted that this occurred only 3 years post the primary implantation.The root cause for the third revision was likely the documented ¿aseptic acetabular loosening¿.It is unknown how much the combination of components contributed to this event.Without the actual product involved, 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: 8295178
• Report Number: 1020279-2019-00364
• Device Sequence Number: 1598226
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (Y/N): N
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2019

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 Expiration Date: 04/02/2023
• Device Catalogue Number: 71342340
• Device Lot Number: 13DM03515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019; 01/08/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/15/2019; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN71344249/BN12JT23055 TI MOD HD SLEEVE +8MM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention