MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-31-056

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

Patient Problems Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

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

It was reported that 4 weeks post surgery, the patient came back with hip problems and noise from the hip.The cause was poly liner dissociation leading to revision surgery and exchange of the poly liner.The pinnacle cup was left well fixed, only liner exchange was performed.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided x-ray image found evidence of disassociation.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN 100 W/GRIPTION 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11590521
• MDR Text Key: 243015294
• Report Number: 1818910-2021-06489
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010227
• UDI-Public: 10603295010227
• Combination Product (y/n): N
• PMA/PMN Number: K090998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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 Model Number: 1217-31-056
• Device Catalogue Number: 121731056
• Device Lot Number: 9591801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX56OD; COMPETITOR HEAD (Z/B); PINN 100 W/GRIPTION 56MM; ALTRX NEUT 32IDX56OD; COMPETITOR HEAD (Z/B); PINN 100 W/GRIPTION 56MM
• Patient Outcome(s): Required Intervention