MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROSTALAC HIGH 105MM STEM SZ1; MISCELLANEOUS JOINT IMPLANTS : PROSTALAC

Catalog Number 154106000

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/20/2013

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Pfs has no allegation.After review of medical records, the patient's prostalac hip was revised into the definitive hip components.Revision notes reported that the surgeon took approximately an hour to remove the cement from the proximal aspect of the femur due to the loose metal component of the prostalac hip which resulted to the cement being in the femoral canal.It was determined in the medical records that three cements were used in the femoral component but was not known which cements were used.Therefore, the lot number was left as unknown.Doi: (b)(6) 2012; dor: (b)(6) 2013; (right hip).

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Per internal procedures, the event information was reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode.Medical records were reviewed.From a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  .

• Brand Name: PROSTALAC HIGH 105MM STEM SZ1
• Type of Device: MISCELLANEOUS JOINT IMPLANTS : PROSTALAC
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8486389
• MDR Text Key: 141015062
• Report Number: 1818910-2019-89833
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: H000004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 154106000
• Device Lot Number: 301134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 108