MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETAB CUP PINN

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

Event Description

It was reported that a eprd detail reports was received which includes safety related data on depuy orthopädie gmbh - cmw®-knochenzement and depuy orthopädie gmbh - smartset®-knochenzement.Cmw cement cmw cement was noted to be involved in 531 primary procedures, 59 revisions was noted via the registry (below).Part number 3325020 (cmw 2mit gentamicin, 20 g) 552 primaries with 57 revisions.Part number 3325040 (cmw 2mit gentamicin, 40 g) 2 primaries with 1 revision.Part number 3335020 (cmw 3mit gentamicin, 20 g) 2 primaries with 1 revision.Part number 3335040 (cmw 3mit gentamicin, 400 g) 5 primaries with 0 revisions.Noted reasons for revision are infection, dislocation, loosening, and unknown/other reason.Products implanted with cmw cement are unknown except there as one revision involving attune (tray, insert, and femoral component) for infection.Smartset cement smartset cement was noted to be involved in 12,274 primary procedures.574 revisions were noted via the registry (below).Part number 3095020 (smartset ghv, 20 g) 3816 primaries with 149 revisions.Part number 3095040 (smartset ghv, 40 g) 6867 primaries with 297 revisions.Part number 8195060 (smartset cemvac and smartset gentamicin 60g) 1283 primaries with 91 revisions.Part number 8195080 (smartset cemvac and smartset gentamicin 80g) 308 primaries with 37 revisions.Noted reasons for revision are infection, dislocation, periprosthetic fracture, aseptic loosening, wear, and unknown/other reason.Products implanted with smartset cement are unknown except the below information provided.114 revisions involving sigma/mbt (tray, insert, and femoral component) - 34 for infection, 4 for dislocation, 5 for fracture (unknown location), 2 for malpositioning/malalignment, 14 for aseptic loosening (unknown device or interface), 4 for wear, and 51 for unknown/other reason.27 revisions involving sigma hp partial (tray, insert, and femoral component) - 2 for infection, 3 for aseptic loosening (unknown device or interface), 1 for wear, and 21 for unknown/other reason.8 revisions involving pinnacle cup (cup and insert) - 1 for infection, 1 for bone fracture, 1 for aseptic loosening of unk cemented stem, and 6 for unknown/other reason.No mention of femoral stem/head involved.3 revisions involving corail cemented stem (stem and femoral head) - 1 for infection and 2 for aspectic loosening (unknown interface).No mention of acetabular liner/acetabular cup involved.2 revisions involving corail and self centering head - 1 for dislocation and 1 for other/unknown.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.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).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18979955
• MDR Text Key: 338618669
• Report Number: 1818910-2024-06688
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETAB CUP PINN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention