MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336456
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a total hip revision due to pain that became progressively worse.The whole system was replaced.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, based on the available information, the reported pain along with cup malposition, heterotopic ossification, trochanteric impingement contributed to the root cause for the device revision.The cup malposition cannot be concluded if it was a change over time and therefore a failure vs an improper position at time of implantation.In addition, the ¿heterotopic ossification¿ cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes could include malposition/ migration of the device or ossification.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF THREE HOLE SHELL 56MM
• 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: 9362833
• Report Number: 1020279-2019-04139
• Device Sequence Number: 14196346
• Product Code: MBL
• UDI-Device Identifier: 03596010454379
• UDI-Public: 03596010454379
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 04/02/2018
• Device Model Number: 71336456
• Device Catalogue Number: 71336456
• Device Lot Number: 08BM05872
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/11/2020
• 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: Hospitalization; Required Intervention