MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM 28MM +6 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-18-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 02/11/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle claim form and medical records received.After review of medical records, it was stated that the patient was admitted due to pain and was found to had developed post-op infection.Irrigation and debridement plus iv antibiotic treatment done on (b)(6) 2008.Subsequently, revision was made on (b)(6) 2008.Revision notes reported purulence between the liner and shell.The acetabulum was also found to be loose without osteal integration.The right hip area was swollen and reddened.Re-revision done on (b)(6) 2009 to remove the non-articulating antibiotic spacer and implantation of definitive implants; non-depuy devices were used.Moreover, during the initial hip replacement on (b)(6) 2007, the srom stem and sleeve were too tight in the bone so the srom stem backed out and femur over reamed to 12mm.A cable was used to avoid insertional fracture.In this course, it resulted to posterior avulsion of the greater trochanter.Later on (b)(6) 2007, an i&d and evacuation of hematoma was done and the avulsion was repaired.Doi: (b)(6) 2007 (cup, liner, sleeve, screws); doi: (b)(6) 2008 (head, stem).Dor: (b)(6) 2008; right hip.

Manufacturer Narrative

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.  product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.  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 did find additional related reports involving pain against the provided product code/lot code combination. per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.A records review will not be performed at this time.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(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were 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 product contribution to the reported event was identified and no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Brand Name: SROM 28MM +6 M HEAD
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9700091
• MDR Text Key: 188806734
• Report Number: 1818910-2020-04596
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 10603295033165
• UDI-Public: 10603295033165
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Model Number: 1365-18-500
• Device Catalogue Number: 136518500
• Device Lot Number: 2218664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR