MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ9 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157001165
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant was being opened when a nurse noticed the tip of the stem had completely punctured through the plastic packaging and the cardboard box, with no other signs of wear on the packaging.Doi- unknown.Dor- (b)(6) 2026.Affected side- right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H11 additional narrative: added: d9.Corrected: d4 primary udi number.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "it was reported that implant was being opened when nurse notice the tip of the stem had completely punctured through not only all of the plastic, but the cardboard box as well.No other signs of wear on the box were shown: i have photos that show the condition of the box and implant.Doi- unknown.Dor- 7th january,2026.Affected side- right hip".The product was returned to depuy synthes for evaluation.Visual inspection revealed the following conditions on the device packaging: 1) card box packaging was found open and with a tab ripped off; 2) the blister was found broken (punctured by the implant inside of it); 3) the tyvek lid was open; 4) the plastic internal packaging appears to be sealed; 5) the blue packaging was also punctured by the implant; and 6) the implant was found un-used.No other anomaly was identified on the evidence provided.Although the packaging was returned in an open condition, evidence suggests the device had been sealed and packaged at the manufacturer prior to when it was opened.No evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Once the product leaves depuy synthes control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to improper storage and manipulation, outside of depuy synthes control.A manufacturing record evaluation was performed for the finished device c35122 lot number, and no non-conformances nor manufacturing irregularities were identified.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the summit por taper sz9 std off would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device c35122 lot number, and no non-conformances nor manufacturing irregularities were identified.Corrected: h3.

• Brand Name: SUMMIT POR TAPER SZ9 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• 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 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24121047
• Report Number: 1818910-2026-01171
• Device Sequence Number: 5987819
• Product Code: LPH
• UDI-Device Identifier: 10603295059400
• UDI-Public: (01)10603295059400(17)260430(10)C35122
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 157001165
• Device Lot Number: C35122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 01/21/2026; 02/26/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/26/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male