MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333325
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the liner not locked properly in to the shell.They used another liner that also not locked.They removed reflection shell 54 and used r3 shell 56 and liner.30 minutes of delay due to this incident.A backup device was available.
Additional Manufacturer Narrative
Reviewing the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that the patient suffered bone loss during the reflection shell removal and not while using the insert in the patient, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: REF XLPE 28 20 DEG 54-56 F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8720155
• Report Number: 1020279-2019-02365
• Device Sequence Number: 19386085
• Product Code: LPH
• UDI-Device Identifier: 03596010455628
• UDI-Public: 03596010455628
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002747
• 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): 11/12/2019

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: 71333325
• Device Lot Number: 18EM23139
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 05/30/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 10/28/2019; 11/12/2019
• 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