MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR ETO NEUT 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122428046

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 08/04/2020

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

The primary surgery was performed on (b)(6) 2016 via tha.It was reported that impingement noise between the cup and the head was found when the patient visited the hospital.The surgeon performed revision surgery on (b)(6) 2020 due to suspicion of liner¿s dislocation and the cup and the head¿s impingement.During the revision surgery, the surgeon confirmed the dislocation of the liner, and the cup impinged the head.Metallosis was found together.The surgeon removed the screw and replaced the liner and the head.He remained the cup because there was no loosening of the cup and he want minimally invasive surgery for the patient.The surgery was completed successfully without any surgical delay.The surgeon commented that cause of dislocation was unknown.He doubted that the dislocation thought to be due to the patient¿s falling and the screwhead¿s slightly protruding.Only falling and screw¿s protruding caused the dislocation? no further information is available.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.The complaint was received into the company with the following comment: the primary surgery was performed on (b)(6) 2016 via tha.It was reported that impingement noise between the cup and the head was found when the patient visited the hospital.The surgeon performed revision surgery on (b)(6) 2020 due to suspicion of liner¿s dislocation and the cup and the head¿s impingement.During the revision surgery, the surgeon confirmed the dislocation of the liner, and the cup impinged the head.Metallosis was found together.The surgeon removed the screw and replaced the liner and the head.He remained the cup because there was no loosening of the cup and he want minimally invasive surgery for the patient.The surgery was completed successfully without any surgical delay.The surgeon commented that cause of dislocation was unknown.He doubted that the dislocation thought to be due to the patient¿s falling and the screwhead¿s slightly protruding.Only falling and screw¿s protruding caused the dislocation? no further information is available.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.As no device has been returned to this point, a physical analysis of the product is not possible.Should the device be returned, the investigation will be reopened and investigated accordingly.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.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.

• Brand Name: PINN MAR ETO NEUT 28IDX46OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10408572
• MDR Text Key: 203109787
• Report Number: 1818910-2020-18150
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 122428046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/19/2020; 10/14/2020
• Supplement Dates FDA Received: 08/27/2020; 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN BANTAM W/GRIPTION 46MM; SCREW; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR