MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 50MM; PRSTHSS,HP,SM-CNSTRND,MTL/CRMC/CRMC/MTL,CMNTD OR UNCMNTD

Model Number	71331850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had stomach and intestinal problem, assessed as device related (only one from s+n), and further described as suspected to be due to excessive use of analgesics and it was resolved through gastroscopy and colonoscopy.
Additional Manufacturer Narrative
Additional info: d10, g7, g9, h2, h3, h6, h10.Results of investigation: it was reported that the patient experienced stomach and intestinal problems post-surgery.The affected r3 acetabular shell, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Per site note, it was suspected that the reported event was caused by excessive use of analgesics.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 0 HOLE ACET SHELL 50MM
• Common Device Name: PRSTHSS,HP,SM-CNSTRND,MTL/CRMC/CRMC/MTL,CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9556158
• Report Number: 1020279-2020-00120
• Device Sequence Number: 11364663
• Product Code: MRA
• UDI-Device Identifier: 03596010597588
• UDI-Public: 03596010597588
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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: 07/08/2019
• Device Model Number: 71331850
• Device Catalogue Number: 71331850
• Device Lot Number: 09GM05274
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 05/06/2020
• 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: Required Intervention