MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL

Model Number	71343216
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision was performed due to incorrect version on the originally implanted acetabular cup.No s+n items were implanted in the revision.
Additional Manufacturer Narrative
Additional information in d1, d2, d4, d11 and g5.
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 it was communicated that no clinically relevant supporting documentation (i.E.Explant, op-notes, x-rays) would be provided; therefore, a thorough medical investigation could not be performed.Reportedly, the root cause for the revision was ¿due to incorrect version on the originally implanted acetabular cup¿ approximately 19 years ago and the surgeon did not fault the devices.The patient impact beyond the reported revision could not be determined.Should clinically relevant documentation become available, the clinical/medical task may be re-evaluated.No further medical assessment can be rendered at this time.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.Some potential probable causes of this event could include a fit/ sizing or alignment issue.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 device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIP IMPLANT
• Common Device Name: PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9474559
• Report Number: 1020279-2019-04407
• Device Sequence Number: 16937585
• Product Code: JDH
• UDI-Device Identifier: 03596010525185
• UDI-Public: 03596010525185
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 11/30/2023
• Device Model Number: 71343216
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 03/05/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/16/2020; 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NO.: 71333580 / LOT NO.: 15AM19572.; PART NO.: 71333580 / LOT NO.: 15AM19572.; PART NO.: 71343216 / LOT NO.: 13MM01036.; PART NO.: 71333580 / LOT NO.: 15AM19572
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention