MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-056

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Ossification (1428); Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Scar Tissue (2060); Discomfort (2330); Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Litigation alleges loosening. Update ad 16 nov 2021 ppf, pfs and medical records received. Ppf has no new allegation. In addition to what previously alleged, pfs alleges stiffness and discomfort. After review of medical records patient was revised was due to loose acetabular component. Operative notes indicated that there were osteophytes present superiorly and anteriorly as well as soft tissue had to be debrided. The broken screw could be seen at that point. It appeared that the flange on the screw head had broken off or worn away and the screw had bent with almost 90 degrees angle posteriorly as the cup traveled posteriorly. The overall quality of the acetabulum was good. There were cystic areas but there were also very sclerotic areas an unusual undulating areas of sclerotic bone presumably due to metal impingement and reaction to wear. There were adhesion present, tendonitis, some slightly grayish fluid and the screw was sitting proud. Doi: (b)(6) 2008 - dor: (b)(6) 2011 (right hip) first revision.

• Brand Name: PINN SECTOR W/GRIPTION 56MM
• 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 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12850892
• MDR Text Key: 281193148
• Report Number: 1818910-2021-25885
• Device Sequence Number: 1
• Product Code: KWA
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1217-32-056
• Device Catalogue Number: 121732056
• Device Lot Number: B3PFH1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/22/2021 Patient Sequence Number: 1

Treatment

12/14 ARTICUL 40MM M SPEC+5.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN SECTOR W/GRIPTION 56MM.; PINNACLE MTL INS NEUT40IDX56OD.; SUMMIT POR TAPER SZ6 HI OFF.