MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121735500

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

Patient Problems Pulmonary Embolism (1498); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Embolism/Embolus (4438); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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

Ppf received.Ppf alleges dislocation, metal wear, metallosis, and fracture component, the unknown liner, unknown head, and unknown component were reported to the impacted product due to the ppf allegations.Doi: (b)(6) 2012 - dor: none reported (right hip).Linked to (b)(4) for the left hip.

Event Description

Medical records were received: on (b)(6) 2012 the patient had a right hip arthroplasty to address degenerative joint disease.Pinnacle acetabular shell, with altrx polyethylene liner and biolox ceramic head with summit femoral stem were implanted with 2 cancellous bone screws were implanted during this procedure.It should be noted that the patient also had a planned diagnostic cystoscopy to address gross hematuria/gross hematoma done.

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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part #121735500/ lot #d00446356 combination.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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part #121735500/ lot #d00446356 combination.

• Brand Name: PINN CAN BONE SCREW 6.5MMX35MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• 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 46581-0988 ; 3035526892
• MDR Report Key: 18788958
• MDR Text Key: 336341177
• Report Number: 1818910-2024-04435
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 121735500
• Device Lot Number: D00446356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/29/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 44IDX62OD; ALTRX +4 NEUT 44IDX62OD; DLT TS CER HD 12/14 44MM +8.5; DLT TS CER HD 12/14 44MM +8.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN SECTOR W/GRIPTION 62MM; PINN SECTOR W/GRIPTION 62MM; SUMMIT DUOFIX TAP SZ3 HI OFF; SUMMIT DUOFIX TAP SZ3 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Race: White