MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN BANTAM W/GRIPTION 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121730044
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that it was confirmed dislocation occurred on (b)(6) 2019 by the x-ray even though there had been no particular problem with the condition after tha surgery performed on (b)(6) 2019.It was reported the tha surgery was performed as follows.The cup 44mm was fixed with 3 screws after it was confirmed the fixation angle by the x-ray.The surgeon trial tested with trial implants except the cup, confirmed dislocation position and leg-length, and explanted the trial implants.The liner (+4 mm,10 degree, 28mm inner diameter)was implanted after washing out.It was planned to use the c stem #2 however it was not able to implant to the femur so the cpt stem (size0 extended offset/manufactured by zimmer) was implanted and fixed by the vacu-mix cement.The surgeon trial tested with the trial head, decided the head length.The delta head (28mm,+3.5mm/ manufactured by zimmer) was fixed and the surgeon confirmed dislocation position and leg-length.The fixation angle of the cup was slightly shifted in comparison with the preoperative plan, but the surgery was completed without any problem and there was no surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: PINN BANTAM W/GRIPTION 44MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8471276
• Report Number: 1818910-2019-89236
• Device Sequence Number: 1104116
• Product Code: LPH
• UDI-Device Identifier: 10603295009948
• UDI-Public: 10603295009948
• Combination Product (Y/N): N
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121730044
• Device Lot Number: HF2953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention