MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +9; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-330

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Swelling/ Edema (4577)

Event Date 02/14/2022

Event Type  Injury  

Event Description

Surgeon reported to bfarm: "condition after hip-tep 3 years ago in (b)(6) (note: other hospital).Currently, since about 6 weeks, increasing swelling in the area of the right hip with ague from time to time and increasing crp values.Condition after hip-tep right side 3 years ago in (b)(6) because of hip dysplasia and multiple surgical interventions.Fall about 2 years ago on the right hip.Currently fractured inlay with various fragments spread far along the proximal femur.Conservative approach for a long time despite of known inlay fracture.Now however probably secondary superinfected foreign body granuloma at the ventral femur with abscess.Intraoperatively there is a fragment with clear purulent secretion.Intraarticularly no macroscopic evidence of infection.The acetabulum as well as the stem are completely fixed and osseous-integrated.Therefore, no tep change but only change of the inlay to pe inlay and merete ceramic head." there was an infantile hip dysplasia which was primarily treated within a reconstruction surgery.In the further course, however, early arthrosis occurred which led to primary implantation.Doi: (b)(6) 2019.Dor: (b)(6) 2022.Right hip.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed, and it can't be determine any device related problem.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 10/14/2018.3) any anomalies or deviations identified in dhr: no non-conformances associated with this lot.4) expiry date: 09/30/2023.5) ifu reference: (b)(4).Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 10/14/2018.3) any anomalies or deviations identified in dhr: no non-conformances associated with this lot.4) expiry date: 09/30/2023.5) ifu reference: (b)(4).

• Brand Name: DELTA CER HEAD 12/14 32MM +9
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13684430
• MDR Text Key: 288690725
• Report Number: 1818910-2022-04138
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033455
• UDI-Public: 10603295033455
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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 Expiration Date: 09/30/2023
• Device Model Number: 1365-32-330
• Device Catalogue Number: 136532330
• Device Lot Number: 8942632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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
• Treatment: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +9; DELTA CER INSERT 32ID X 48OD; PINNACLE 100 ACET CUP 48MM; TRI-LOCK BPS SZ 2 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Sex: Female