MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE BANTAM ACET CUP 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-044
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	02/11/2008
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE BANTAM ACET CUP 44MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9700104
• Report Number: 1818910-2020-04589
• Device Sequence Number: 3147680
• Product Code: KWA
• UDI-Device Identifier: 10603295009580
• UDI-Public: 10603295009580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2012
• Device Model Number: 1217-20-044
• Device Catalogue Number: 121720044
• Device Lot Number: B1EB71000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: Required Intervention
• Patient Age: 52 YR