MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM; PROSTHSIS,HIP,SMICONSTRAD METL/CRMIC/CRMIC/MTAL,CMNTDORUNCMNTD

Catalog Number	71335560
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that during the screw insertion was unsuccessful.Radiography confirmed the tip of the cancellous screw penetrated through the iliac cortex into abdomen.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the available information, the root cause for the ¿pneumoperitoneum and perforated sigmoid diverticulitis¿ cannot be concluded.The provided x-ray pictures and the intraoperative notes are inconclusive.Also the intra-operative notes site diverticulitis as the contributing factor for the event.No current information has been provided except for the permanent colostomy.On 03/06/2019: (addendum) review of the received office visit note dated 05/19/2017 indicated that there was a rupture of a diverticula after taking magnesium citrate which was captured in the previous complaint.There was reported hip arthroplasty improvement until 5 weeks prior to the may 2017 visit.The follow-up visit noted pain reportedly on his side and the surgeon felt it was likely gt bursitis ¿based on the palpation of a very tight iliotibial band and point tenderness over the gt¿ with heterotopic ossification about the left hip.Neither prosthetic loosening nor infection was suspected and the information provided did not warrant further changes to the medical investigation.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: R3 3 HOLE ACET SHELL 60MM
• Common Device Name: PROSTHSIS,HIP,SMICONSTRAD METL/CRMIC/CRMIC/MTAL,CMNTDORUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8308598
• Report Number: 1020279-2019-00465
• Device Sequence Number: 62214
• Product Code: MRA
• UDI-Device Identifier: 03596010598288
• UDI-Public: 03596010598288
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 07/15/2024
• Device Catalogue Number: 71335560
• Device Lot Number: 14GM12514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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