MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-32-062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	10/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation: lawyer.(b)(4).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
Claim letter received alleging pain, inability to walk without crutches, inability to move, trouble sleeping, spasms, discomfort, suffering, significant loss of amenity.Doi: (b)(6) 2017 - dor: (b)(6) 2018 (right hip).Email notification from (b)(6) received alleging infection.Primary surgery date has been updated to (b)(6) 2015 and revision date to (b)(6) 2016.The revision on (b)(6) 2017 noted on the (b)(6) appendix b matches with the second stage revision mentioned on the original claim letter.It was indicated that during this date, the infection had settled and the client's hip was now put back in place.It is unknown if the definitive implants are from depuy.It should be noted that around ten days after the definitives were implanted, the patient had experienced pain again.It was also indicated that this claim is not actively litigated.Doi: (b)(6) 2015 - dor:(b)(6) 2016 (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN SECTOR W/GRIPTION 62MM
• 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: 9769545
• Report Number: 1818910-2020-06329
• Device Sequence Number: 14044987
• Product Code: LPH
• UDI-Device Identifier: 10603295010357
• UDI-Public: 10603295010357
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1217-32-062
• Device Catalogue Number: 121732062
• Device Lot Number: 350330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 05801441/G6106999; 63642136/G6166311; 66017569/84294526; 66017569/85294526
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR