MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PINNACLE SECTOR II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722056

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Synovitis (2094); Weakness (2145); Hypoesthesia (2352); Inadequate Osseointegration (2646); Not Applicable (3189)

Event Date 06/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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, loosening of the implant, popping in hip, numbness, tingling, and weakness.Doi: (b)(6) 2006 dor: none reported (left side).Patient is a resident of (b)(6).Update: 11/19/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update 2/17/16-pfs and medical records received.After review of the medical records for mdr reportability, a dor was provided.The revision operative note indicated pain and synovitis.There was no mention of loosening.The right hip ((b)(4)) was revised for elevated metal ion levels-no labs), so the stem will be added to this hip as well.The complaint was updated on: 3/4/2016.Update ad 24 april 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.Ppf alleges loosening of cup and stem, metal wear and metallosis.Added cup 121722056, lot # at3f11000.Doi: (b)(6) 2006; dor: (b)(6) 2015; (left hip).(b)(4)-left hip.(b)(4)-right hip.

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.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7817874
• MDR Text Key: 118272834
• Report Number: 1818910-2018-67702
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121722056
• Device Lot Number: AT3F11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2006
• 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: 79 YR
• Patient Weight: 100