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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rep inadvertently retrieved the 40mm femoral head and from stock and checked the implant off with two members of the operating room (or) staff.The rep then handed the implant to the circulating nurse.The nurse then opened the implant to the sterile field, and the 40 mm head was implanted.A 44 inner diameter liner was already implanted, so there was a discrepancy in head and liner size.The error was noticed the following day, and the surgeon was immediately notified.A revision surgery was then performed on (b)(6) 2018 with no additional issues.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A visual inspection of the photos attached to the complaint can't verify the stated failure described in the complaint description.The provided photos does not show the size of the actual implants.A clinical evaluation was conducted and reportedly during a thr procedure the incorrect modular head was implanted and a revision surgery was performed two days later.The major contributing factor to the reported revision is due to a procedural error and is not due to a mal-performance of the prosthetic components.The patient status beyond the revision not be determined.No further medical assessment is needed at this time based on the information provided.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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: 8245387
• Report Number: 1020279-2019-00157
• Device Sequence Number: 2701654
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 18KM15800
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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: Hospitalization; Required Intervention