MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-058

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 11/14/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Initial reporter occupation: lawyer.((b)(4)) used to capture the surgical intervention and difficulty walking if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: update 4/5/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported swelling, heat, pain, difficulty walking and standing, inability to climb stairs normally and unable to lift greater than 15 pounds.Medical records reported that components implanted between (b)(6) 2014 and (b)(6) 2014 were competitor products.Depuy components were implanted on (b)(6) 2014 and during hospital stay patient dislocated her hip on (b)(6) 2014 with a closed reduction and again on (b)(6) 2014 with a revision surgery for dislocation.Surgical report from (b)(6) 2014 reported that cup was implanted at 10 degrees of anteversion but was not revised and there was severe tensor damage.The complaint was updated on: apr 29, 2016.Update ad 10 aug 2018: (b)(4) has been reopened under (b)(4) due to the receipt of ppf and medical records.There were no new allegations reported.Added law firm.Doi: (b)(6) 2014 - dor: (b)(6) 2014 (right hip).

Manufacturer Narrative

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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN SECTOR W/GRIPTION 58MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6107428552
• MDR Report Key: 9129295
• MDR Text Key: 166020673
• Report Number: 1818910-2019-106579
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295010333
• UDI-Public: 10603295010333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-32-058
• Device Catalogue Number: 121732058
• Device Lot Number: 588119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 75