MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED LINER 10 DEGREE OBLIQUE FACE 32 MM; PROSTHESIS, HIP

Catalog Number	00615405032
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a left hip revision approximately three years and three months¿ post implantation due to a dislocation.The head, shell and liner were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00205.D10: cat #:00877503202 / biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 / lot #: 2991000.Cat #: 00620005422 / shell porous with cluster holes 54 mm o.D./ lot: 62740870 unknown stem.G2: brazil.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified liner was confirmed fractured at the rim.Nicks, gouges, and scratches were noted to the inner and outer spherical surfaces as well as the polar boss and anti rotation scallops.Screw holes were present in the liner spherical shape.Constraining ring was returned with liner.Ring shows nicks and gouges from use.No other damage was noted.Lot number confirmed.The device was sent to sem for further analysis: item returned is a conventional uhmwpe trilogy constrained liner.The liner has an apparent fracture of the poly rim which mates with the constraining ring; approximately 1/6 of the circumference of the rim is missing.No uhmwpe fragments from the rim nor the constraining ring itself were returned for examination.There is noticeable plastic deformation on the superior side of the uhmwpe rim that are possibly due to impingement; it is not clear whether the deformation would have occurred before or after the possible fracture and dislocation.There is also evidence of abrasions or gouging on the lateral side of the liner, including between the offset rim and the constraining rim, although it is also not clear at what point the damage occurred.There is also plastic deformation on the pole extension of the liner, which may possibly indicate misalignment between the liner and the acetabular shell.Conclusion: the fracture of the rim is potentially due to overloading, possibly exacerbated by misalignment between the liner and the acetabular shell leading to unsupported or under supported loading of the rim and subsequent fatigue failure.However, based on third party review, there is no evidence of impingement or misalignment of the implants from the provided xrays.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: on 10 march 2023, pt dislocated while sitting on the toilet and experienced pain; descended stairs while dislocated.Unable to reduce hip, scheduled for revision on 10 march 2023 but was delayed 1 day due to product.Had negative bacterial growth after 24 hours.Revision on 11 march 2023; removed shell, liner, ring, and head but no mention of explant of stem.Competitor product implanted; the shell was removed and a larger shell was implanted during the revision, leading to the bone loss noted in the legal documentation.Review of medical records also noted "dislocation of the left hip prosthesis due to failure of osteosynthesis material." however based on third party review, no lucency, radiolucency, or failure to osteointegrate was confirmed from the provided xrays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall size of the implant is appropriate.Left acetabular cup inclination angle: 45 degrees.Femoral head superior dislocation is seen on 3/10/23.No liner fracture seen.A constrained acetabular cup liner is seen.No contributing factors are definitely identified.It was reported that a closed reduction was attempted between the constrained liner and femoral head.Per the associated trilogy acetabular system constrained liner surgical technique, "closed reduction of this device is not possible.Although the constrained hip liner provides resistance to dislocation, it can dislocate if subjected to excessive loading.Once dislocated, additional surgery will be required to reduce the joint." therefore, attempted reduction would be considered use error.However, it is unknown if the attempted closed reduction caused or contributed to the damage noted on the returned product, or if the damage was present prior to the reduction.Therefore, a definitive root cause cannot be determined.The reported event is confirmed by the returned product and provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: CONSTRAINED LINER 10 DEGREE OBLIQUE FACE 32 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16972571
• Report Number: 0001822565-2023-01340
• Device Sequence Number: 12405938
• Product Code: KWZ
• UDI-Device Identifier: 00889024117303
• UDI-Public: (01)00889024117303(17)231031(10)64100289
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 00615405032
• Device Lot Number: 64100289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 09/08/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/12/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 120 KG