MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 36 +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-52-100

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

Patient Problems Inflammation (1932); Pain (1994); Pocket Erosion (2013); Impaired Healing (2378); Swelling/ Edema (4577)

Event Date 04/17/2019

Event Type  Injury  

Event Description

Unfiled claim and pinnacle mom medical records received. After review of the medical records the patient was revised to address pain and failure of mechanical right total hip arthroplasty. Operative findings suggestion of trochanteric bursitis without presence of pseudotumor. Operative note reported some attenuation in the fascia right trochanter. Previous abductor repair not completely healed, there was new erosion and large amount of fluid. Pathology report evidence of trochanteric bursitis. Doi: (b)(6) 2011; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Product complaint # (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.

• Brand Name: ASPHERE M SPEC 12/14 36 +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12916550
• MDR Text Key: 281596693
• Report Number: 1818910-2021-26925
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1365-52-100
• Device Catalogue Number: 136552100
• Device Lot Number: 3276158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2011
• 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: 12/02/2021 Patient Sequence Number: 1

Treatment

AML LG STATURE 15.0MM; ASPHERE M SPEC 12/14 36 +5; PINN SECTOR W/GRIPTION 54MM; PINNACLE MTL INS NEUT36IDX54OD