MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335548
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during artificial hip replacement surgery, screws were used for fixation and one of the screws passed directly through the acetabulum cup, surgeon used another two screws for fixation.One of the screws was left in the patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.A visual examination was unable to be performed without the actual device; only the outer box was the returned.A clinical analysis indicated that the provided x-ray confirms 3 retained screws embedded in the bone with one completely through the shell.The root cause of the reported issue could be due to a procedural/user event but the screws remained implanted so were not available to be returned for testing.Since the embedded screw is comprised of bio-compatible material, migration is not likely since the screw is contained within the bone as the single image x-ray shows.The impact to the patient beyond the retained implantable screw cannot be determined.No further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part did not reveal additional complaints for the listed batch.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: R3 3 HOLE ACET SHELL MM48
• 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: 8044712
• Report Number: 1020279-2018-02415
• Device Sequence Number: 1643478
• Product Code: MBL
• UDI-Device Identifier: 03596010598226
• UDI-Public: 03596010598226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71335548
• Device Lot Number: 17LM17003
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 10/08/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 11/07/2018; 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR