MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; HIP METAL ACETABULAR LINERS

Catalog Number 121887352

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Joint Dislocation (2374)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 on (b)(6) 2007, the patient underwent the primary surgery via tha with implants in question at another hospital.It was mom (metal on metal) because of frequent dislocation, an x-ray showed that the cup was placed at an abduction angle of about 50 degrees.Therefore, revision surgery was performed on (b)(6) 2024.In that case, the metallosis was confirmed by installation at the mom (metal on metal).The surgeon performed as much implant removal and revision as possible.The cup installation angle was about 50 degrees, which may have caused localized load stress on the metal insert and metal head.This may have led to corrosion between the head and neck.No further information is available.Remark: the cup was registered as polo on (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- pinnacle mtl ins neut36idx52od.Product code:- 121887352.Lot no:- 2283199.Quantity of manufactured:-(b)(4).Date of manufacturing:- nov 2006.Ant anomalies or deviations identified in dhr:- n/a.Expiry date:- 29nov2011.Ifu reference:- (b)(4).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: product description:- pinnacle mtl ins neut36idx52od.Product code:- 121887352.Lot no:- 2283199.Quantity of manufactured:- (b)(4).Date of manufacturing:- nov 2006.Ant anomalies or deviations identified in dhr:- n/a.Expiry date:- 29nov2011.Ifu reference:- (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19133098
• MDR Text Key: 340477825
• Report Number: 1818910-2024-08227
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 Expiration Date: 11/29/2011
• Device Catalogue Number: 121887352
• Device Lot Number: 2283199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS +0.; S-ROM*SCREW,6.5MM DIA,15MM LG.; S-ROM*SCREW,6.5MM DIA,20MM LG.; S-ROM*SCREW,6.5MM DIA,30MM LG.; SROM 9/10 18X12X135 30.
• Patient Outcome(s): Required Intervention