MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 ACET CUP 56MM; HIP ACETABULAR CUP

Catalog Number 121701056

Device Problem Loss of Osseointegration (2408)

Patient Problems Joint Swelling (2356); No Information (3190)

Event Date 07/07/2010

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

New etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint ¿ bilateral patient.Litigation alleges that patient developed pain in his hips.Update: 02/10/2017 please transfer (b)(4).Update 02/10/2017 ¿pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the pfs reports pain and limited mobility.The revision surgery notes reported ¿ectopic calcification¿ (heterotopic ossification) and loose acetabulum, and effusion.The complaint was updated on: 03/06/2017.

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 100 ACET CUP 56MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 6380011
• MDR Text Key: 69143704
• Report Number: 1818910-2017-14032
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 121701056
• Device Lot Number: AT3FP1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 09/19/2018
• 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: 55 YR
• Patient Weight: 82