MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Cyst(s) (1800); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Osteolysis (2377); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 12/04/2020

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

Literature article entitled "pseudotumor and repeated dislocation after total hip arthroplasty with ceramic-on-metal bearing: a case report" written by yin-qiao du, tao luo, jing-yang sun, hai-yang ma, ming ni, and yong-gang zhou. Published by annals of palliative medicine published online/accepted by publisher 15 jul 2020 was reviewed. The article's purpose was to follow the case of a (b)(6) year-old female who underwent multiple revisions and manual reductions involving ceramic-on-metal hip products. The original primary operation occurred in december 2009 involving a cementless pinnacle cup and s-rom stem. Radiographic and intra-operative images can be found on pages 3 and 4 of the literature article. Depuy products with known adverse event(s): femoral head x 2, femoral stem, femoral cone, acetabular cup, acetabular screws x 2, acetabular liner. Adverse events: first revision with femoral head exchange to address pain, instability, difficulty walking, and noise. Subsequent multiple manual reductions to address dislocations leading to an eventual head, liner, and acetabular screw x 2 revision to address pain, fall, decreased range of motion, pseudotumor, cyst, edema, osteolysis, necrosis, inflammation, bone injury, and liner metal wear as well a placement of a cable system to address a femoral bone fracture.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• Type of Device: METAL ACETABULAR LINER
• 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 ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12688510
• MDR Text Key: 279006769
• Report Number: 1818910-2021-23398
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 10/25/2021 Patient Sequence Number: 1