MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722058

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

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Hypoesthesia (2352); Not Applicable (3189)

Event Date 12/27/2011

Event Type  Injury  

Manufacturer Narrative

(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.Reporter is an attorney.

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint- litigation alleges that patient has experienced pain, difficulty walking, and multiple dislocations, nerve damage that included numbness in left calf down to her foot, bone loss, as well as leg length discrepancy.Doi: (b)(6) 2003; dor: (b)(6) 2011; (left side).Patient is a resident of (b)(6).Update: 12/13/2012 pfs was received from legal.Part/lot information was identified by invoice search.Update rec'd (1/9/2014) litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from clicking, popping, grinding, swelling and discomfort.There is no additional information that would affect the investigation.The complaint was updated on: 02/07/2014.Update ad 25 april 2018: (b)(4) has been reopened under (b)(4) due to receipt of pff and sticker sheets. there was no new allegation found in the ppf.However, the cup was added in the impacted product as it was removed during the revision surgery.

• Brand Name: PINNACLE SECTOR II CUP 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 drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7841888
• MDR Text Key: 119044685
• Report Number: 1818910-2018-68334
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009856
• UDI-Public: 10603295009856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121722058
• Device Lot Number: XL8D71018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2003
• 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: 69 YR
• Patient Weight: 91