MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 58MM; HIP ACETABULAR CUP

Catalog Number 121720058

Device Problem Loss of Osseointegration (2408)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Swelling (2356)

Event Date 11/13/2009

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Litigation received alleging patient was revised to address pain, discomfort, metallosis, elevated ions and difficulty ambulating.Update 03/10/2017 ¿pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, part/lot numbers provided.Additionally, complete abductor insufficiency was noted with complete loss of the trochanter.During the procedure, the surgeon reported that a large effusion was encountered.The trochanter was completely deficient and the ilium was deficient as well.The acetabular shell was found to be grossly loose.The complaint was updated on: 03/31/2017.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4).

Event Description

Ppf alleges metal wear.

Manufacturer Narrative

Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.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.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.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.

• Brand Name: PINNACLE MULTIHOLE II CUP 58MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6451139
• MDR Text Key: 71459759
• Report Number: 1818910-2017-15783
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 121720058
• Device Lot Number: X2SCV1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/31/2017
• Supplement Dates Manufacturer Received: Not provided; 08/05/2019; 11/14/2019
• Supplement Dates FDA Received: 04/28/2017; 08/06/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 125