MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 300 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-056
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	02/29/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: articuleze m head 36mm +8.5 hip femoral head; pinnacle mtl ins neut36idx56od hip acetabular liner; pinnacle 300 acet cup 56mm hip acetabular cup; summit duofix tap sz9 hi off hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).
Event or Problem Description
Litigation papers allege shortly after surgery, patient began experiencing pain and tenderness in his left hip and groin.It is also alleged the pain and tenderness has never gone away and often is so unbearable that patient cannot stand or walk.Update ppf alleges loosening of cup, loosening of stem, metal wear, metallosis, and elevated metal ions.Ppf also alleges pulmonary embolism after the first revision, however, it is not suggested that depuy products were contributory or involved.Doi: (b)(6) 2007 - dor: (b)(6) 2012; (left 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.Device history lot: null device history batch: null.Device history review: null.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.

• Brand Name: PINNACLE 300 ACET CUP 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8089288
• Report Number: 1818910-2018-76025
• Device Sequence Number: 13812392
• Product Code: LPH
• UDI-Device Identifier: 10603295008675
• UDI-Public: 10603295008675
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 04/01/2017
• Device Model Number: 1217-03-056
• Device Catalogue Number: 121703056
• Device Lot Number: BR1CM1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/03/2020
• 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: 62 YR
• Patient Weight: 102